Health product recall

NATRELLE INSPIRA TRL, TRLP, TRM, TRF, TRX TruForm 1 (responsive), NATRELLE INSPIRA TSL,TSLP, TSM, TSF, TSX TruForm 2 (soft touch), NATRELLE 410FL, 410ML, 410LL, 410FM, 410MM, 410LM, 410FF, 410MF, 410LF, 410FX, 410MX, 410LX TruForm Silicone -Filled Br...

Starting date:
May 30, 2019
Posting date:
June 7, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70139



Last updated: 2019-06-07

Affected Products

A. NATRELLE INSPIRA TRL TruForm 1 (responsive)

B. NATRELLE INSPIRA TRLP TruForm 1 (responsive)

C. NATRELLE INSPIRA TRM TruForm 1 (responsive)

D. NATRELLE INSPIRA TRF TruForm 1 (responsive)

E. NATRELLE INSPIRA TRX TruForm 1 (responsive)

F. NATRELLE INSPIRA TSL TruForm 2 (soft touch)

G. NATRELLE INSPIRA TSLP TruForm 2 (soft touch)

H. NATRELLE INSPIRA TSM TruForm 2 (soft touch)

I. NATRELLE INSPIRA TSF TruForm 2 (soft touch)

J. NATRELLE INSPIRA TSX TruForm 2 (soft touch)

K. NATRELLE 410FL TruForm Silicone - Filled Breast Implant

L. NATRELLE 410ML TruForm Silicone - Filled Breast Implant

M. NATRELLE 410LL TruForm Silicone - Filled Breast Implant

N. NATRELLE 410FM TruForm Silicone - Filled Breast Implant

O. NATRELLE 410MM TruForm Silicone - Filled Breast Implant

P. NATRELLE 410LM TruForm Silicone - Filled Breast Implant

Q. NATRELLE 410FF TruForm Silicone - Filled Breast Implant

R. NATRELLE 410MF TruForm Silicone - Filled Breast Implant

S. NATRELLE 410LF TruForm Silicone - Filled Breast Implant

T. NATRELLE 410FX TruForm Silicone - Filled Breast Implant

U. NATRELLE 410MX TruForm Silicone - Filled Breast Implant

V. NATRELLE 410LX TruForm Silicone - Filled Breast Implant

W. NATRELLE 410FF TruForm Soft Touch Silicone - Filled Breast Implant

X. NATRELLE 410FL TruForm Soft Touch Silicone - Filled Breast Implant

Y. NATRELLE 410FM TruForm Soft Touch Silicone - Filled Breast Implant

Z. NATRELLE 410LF TruForm Soft Touch Silicone - Filled Breast Implant

AA. NATRELLE 410LL TruForm Soft Touch Silicone - Filled Breast Implant

AB. NATRELLE 410LM TruForm Soft Touch Silicone - Filled Breast Implant

AC. NATRELLE 410MF TruForm Soft Touch Silicone - Filled Breast Implant

AD. NATRELLE 410ML TruForm Soft Touch Silicone - Filled Breast Implant

AE. NATRELLE 410MM TruForm Soft Touch Silicone - Filled Breast Implant

Reason

Health Canada has suspended the licenses for Allergan's Biocell textured breast implants (the only macro-textured implants available in Canada), based upon the rare but serious risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), Allergan is voluntarily recalling BioCell breast implants as a precautionary measure.

Affected products

A. NATRELLE INSPIRA TRL TruForm 1 (responsive)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TRL110

N-TRL125

N-TRL140

N-TRL170

N-TRL200

N-TRL230

N-TRL260

N-TRL290

N-TRL320

N-TRL350

N-TRL380

N-TRL410

N-TRL460

N-TRL510

N-TRL560

N-TRL610

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


B. NATRELLE INSPIRA TRLP TruForm 1 (responsive)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TRLP125

N-TRLP145

N-TRLP165

N-TRLP190

N-TRLP205

N-TRLP220

N-TRLP235

N-TRLP250

N-TRLP265

N-TRLP280

N-TRLP300

N-TRLP320

N-TRLP340

N-TRLP360

N-TRLP400

N-TRLP440

N-TRLP490

N-TRLP540

N-TRLP590

N-TRLP640

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


C. NATRELLE INSPIRA TRM TruForm 1 (responsive)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TRM140

N-TRM175

N-TRM195

N-TRM210

N-TRM240

N-TRM255

N-TRM275

N-TRM295

N-TRM310

N-TRM330

N-TRM345

N-TRM360

N-TRM375

N-TRM405

N-TRM445

N-TRM485

N-TRM520

N-TRM560

N-TRM600

N-TRM640

N-TRM685

N-TRM755

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


D. NATRELLE INSPIRA TRF TruForm 1 (responsive)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TRF180

N-TRF200

N-TRF220

N-TRF240

N-TRF265

N-TRF295

N-TRF325

N-TRF335

N-TRF345

N-TRF365

N-TRF385

N-TRF415

N-TRF450

N-TRF485

N-TRF520

N-TRF560

N-TRF605

N-TRF650

N-TRF695

N-TRF745

N-TRF770

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


E. NATRELLE INSPIRA TRX TruForm 1 (responsive)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TRX205

N-TRX225

N-TRX255

N-TRX285

N-TRX310

N-TRX340

N-TRX375

N-TRX400

N-TRX420

N-TRX445

N-TRX470

N-TRX495

N-TRX525

N-TRX545

N-TRX560

N-TRX580

N-TRX615

N-TRX650

N-TRX700

N-TRX750

N-TRX800

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


F. NATRELLE INSPIRA TSL TruForm 2 (soft touch)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TSL110

N-TSL125

N-TSL140

N-TSL170

N-TSL200

N-TSL230

N-TSL260

N-TSL290

N-TSL320

N-TSL350

N-TSL380

N-TSL410

N-TSL460

N-TSL510

N-TSL560

N-TSL610

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


G. NATRELLE INSPIRA TSLP TruForm 2 (soft touch)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TSLP125

N-TSLP145

N-TSLP165

N-TSLP190

N-TSLP205

N-TSLP220

N-TSLP235

N-TSLP250

N-TSLP265

N-TSLP280

N-TSLP300

N-TSLP320

N-TSLP340

N-TSLP360

N-TSLP400

N-TSLP440

N-TSLP490

N-TSLP540

N-TSLP590

N-TSLP640

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


H. NATRELLE INSPIRA TSM TruForm 2 (soft touch)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TSM140

N-TSM175

N-TSM195

N-TSM210

N-TSM240

N-TSM255

N-TSM275

N-TSM295

N-TSM310

N-TSM330

N-TSM345

N-TSM360

N-TSM375

N-TSM405

N-TSM445

N-TSM485

N-TSM520

N-TSM560

N-TSM600

N-TSM640

N-TSM685

S-TSM755

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


I. NATRELLE INSPIRA TSF TruForm 2 (soft touch)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TSF180

N-TSF200

N-TSF220

N-TSF240

N-TSF265

N-TSF295

N-TSF325

N-TSF335

N-TSF345

N-TSF365

N-TSF385

N-TSF415

N-TSF450

N-TSF485

N-TSF520

N-TSF560

N-TSF605

N-TSF650

N-TSF695

N-TSF745

N-TSF770

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


J. NATRELLE INSPIRA TSX TruForm 2 (soft touch)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-TSX205

N-TSX225

N-TSX255

N-TSX285

N-TSX310

N-TSX340

N-TSX375

N-TSX400

N-TSX420

N-TSX445

N-TSX470

N-TSX495

N-TSX525

N-TSX545

N-TSX560

N-TSX580

N-TSX615

N-TSX650

N-TSX700

N-TSX750

N-TSX800

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


K. NATRELLE 410FL TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-FL095-120

N-27-FL100-140

N-27-FL105-170

N-27-FL110-190

N-27-FL115-220

N-27-FL120-250

N-27-FL125-285

N-27-FL130-320

N-27-FL135-360

N-27-FL140-400

N-27-FL145-440

N-27-FL150-495

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


L. NATRELLE 410ML TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-ML095-110

N-27-ML100-125

N-27-ML105-150

N-27-ML110-170

N-27-ML115-195

N-27-ML120-220

N-27-ML125-250

N-27-ML130-285

N-27-ML135-320

N-27-ML140-360

N-27-ML145-390

N-27-ML150-440

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


M. NATRELLE 410LL TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-LL095-100

N-27-LL100-115

N-27-LL105-135

N-27-LL110-160

N-27-LL115-180

N-27-LL120-210

N-27-LL125-240

N-27-LL130-270

N-27-LL135-300

N-27-LL140-340

N-27-LL145-370

N-27-LL150-415

N-27-LL155-455

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


N. NATRELLE 410FM TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-FM095-155

N-27-FM100-180

N-27-FM105-205

N-27-FM110-235

N-27-FM115-270

N-27-FM120-310

N-27-FM125-350

N-27-FM130-395

N-27-FM135-440

N-27-FM140-500

N-27-FM145-550

N-27-FM150-605

N-27-FM155-670

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


O. NATRELLE 410MM TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-MM095-135

N-27-MM100-160

N-27-MM105-185

N-27-MM110-215

N-27-MM115-245

N-27-MM120-280

N-27-MM125-320

N-27-MM130-360

N-27-MM135-400

N-27-MM140-450

N-27-MM145-500

N-27-MM150-555

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


P. NATRELLE 410LM TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-LM095-115

N-27-LM100-140

N-27-LM105-160

N-27-LM110-190

N-27-LM115-220

N-27-LM120-250

N-27-LM125-285

N-27-LM130-320

N-27-LM135-360

N-27-LM140-400

N-27-LM145-450

N-27-LM150-495

N-27-LM155-545

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


Q. NATRELLE 410FF TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-FF095-160

N-27-FF100-185

N-27-FF105-220

N-27-FF110-255

N-27-FF115-290

N-27-FF120-335

N-27-FF125-375

N-27-FF130-425

N-27-FF135-475

N-27-FF140-535

N-27-FF145-595

N-27-FF150-655

N-27-FF155-740

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


R. NATRELLE 410MF TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-MF095-140

N-27-MF100-165

N-27-MF105-195

N-27-MF110-225

N-27-MF115-255

N-27-MF120-295

N-27-MF125-335

N-27-MF130-375

N-27-MF135-420

N-27-MF140-470

N-27-MF145-525

N-27-MF150-580

N-27-MF155-640

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


S. NATRELLE 410LF TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-LF095-125

N-27-LF100-150

N-27-LF105-175

N-27-LF110-205

N-27-LF115-240

N-27-LF120-270

N-27-LF125-310

N-27-LF130-350

N-27-LF135-390

N-27-LF140-440

N-27-LF145-490

N-27-LF150-540

N-27-LF155-595

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


T. NATRELLE 410FX TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-FX095-185

N-27-FX100-215

N-27-FX105-245

N-27-FX110-280

N-27-FX115-315

N-27-FX120-360

N-27-FX125-410

N-27-FX130-450

N-27-FX135-495

N-27-FX140-560

N-27-FX145-615

N-27-FX150-690

N-27-FX155-775

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


U. NATRELLE 410MX TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-MX095-165

N-27-MX100-195

N-27-MX105-225

N-27-MX110-255

N-27-MX115-290

N-27-MX120-325

N-27-MX125-370

N-27-MX130-410

N-27-MX135-445

N-27-MX140-520

N-27-MX145-550

N-27-MX150-620

N-27-MX155-685

N-27-MX160-765

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


V. NATRELLE 410LX TruForm Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-27-LX095-145

N-27-LX100-175

N-27-LX105-195

N-27-LX110-225

N-27-LX115-255

N-27-LX120-290

N-27-LX125-330

N-27-LX130-365

N-27-LX135-405

N-27-LX140-455

N-27-LX145-515

N-27-LX150-570

N-27-LX155-625

N-27-LX160-685

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


W. NATRELLE 410FF TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-FF095-160

N-ST-FF100-185

N-ST-FF105-220

N-ST-FF110-255

N-ST-FF115-290

N-ST-FF120-335

N-ST-FF125-375

N-ST-FF130-425

N-ST-FF135-475

N-ST-FF140-535

N-ST-FF145-595

N-ST-FF150-655

N-ST-FF155-740

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


X. NATRELLE 410FL TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-FL100-140

N-ST-FL110-190

N-ST-FL115-220

N-ST-FL120-250

N-ST-FL130-320

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


Y. NATRELLE 410FM TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-FM095-155

N-ST-FM100-180

N-ST-FM105-205

N-ST-FM110-235

N-ST-FM115-270

N-ST-FM120-310

N-ST-FM125-350

N-ST-FM130-395

N-ST-FM135-440

N-ST-FM140-500

N-ST-FM145-550

N-ST-FM150-605

N-ST-FM155-670

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


Z. NATRELLE 410LF TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-LF095-125

N-ST-LF100-150

N-ST-LF105-175

N-ST-LF110-205

N-ST-LF115-240

N-ST-LF120-270

N-ST-LF125-310

N-ST-LF130-350

N-ST-LF135-390

N-ST-LF140-440

N-ST-LF145-490

N-ST-LF150-540

N-ST-LF155-595

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


AA. NATRELLE 410LL TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-LL105-135

N-ST-LL115-180

N-ST-LL120-210

N-ST-LL125-240

N-ST-LL135-300

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


AB. NATRELLE 410LM TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-LM100-140

N-ST-LM110-190

N-ST-LM115-220

N-ST-LM120-250

N-ST-LM130-320

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


AC. NATRELLE 410MF TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-MF095-140

N-ST-MF100-165

N-ST-MF105-195

N-ST-MF110-225

N-ST-MF115-255

N-ST-MF120-295

N-ST-MF125-335

N-ST-MF130-375

N-ST-MF135-420

N-ST-MF140-470

N-ST-MF145-525

N-ST-MF150-580

N-ST-MF155-640

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


AD. NATRELLE 410ML TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-ML100-125

N-ST-ML110-170

N-ST-ML115-195

N-ST-ML120-220

N-ST-ML130-285

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM


AE. NATRELLE 410MM TruForm Soft Touch Silicone - Filled Breast Implant

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

N-ST-MM095-135

N-ST-MM100-160

N-ST-MM105-185

N-ST-MM110-215

N-ST-MM115-245

N-ST-MM120-280

N-ST-MM125-320

N-ST-MM130-360

N-ST-MM135-400

N-ST-MM140-450

Companies
Manufacturer

ALLERGAN

MARLOW INTERNATIONAL, PARKWAY

MARLOW, BUCKINGHAMSHIRE,

SL7 1YL

UNITED KINGDOM