Health product recall

Suture-Based Repair Systems (2020-09-10)

Starting date:
September 10, 2020
Posting date:
September 25, 2020
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-74017



Last updated:
2020-09-25

Affected Products

  1. OSTEORAPTOR 2.9 SUTURE ANCHOR W/TWO ULTRABRAID SUTURES
  2. OSTEORAPTOR 2.9 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE
  3. OSTEORAPTOR 2.3 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE
  4. TWINFIX AB 6.5 SUTURE ANCHOR WITH NEEDLES
  5. FAST-FIX AB CURVED NEEDLE MENISCAL REPAIR SYSTEM WITH SUTURE BAR
  6. RAPTORMITE 3.7 AB W/NEEDLES AND TWO #0 ULTRABRAID, WHITE AND COBRAID BLUE
  7. TWINFIX ULTRA HA SUTURE ANCHOR W/THREE ULTRABRAID SUTURES
  8. OSTERAPTOR CURVED 2.3 SUTURE ANCHOR
  9. TWINFIX ULTRA HA 4.5MM SUTURE ANCHOR W/SUTURES AND NEEDLES
  10. TWINFIX ULTRA HA 5.5MM SUTURE ANCHOR W/SUTURES AND NEEDLES
  11. HEALICOIL REGENESORB SUTURE ANCHOR
  12. HEALICOIL REGENESORB SUTURE ANCHOR WITH ONE ULTRATAPE AND ONE ULTRABRAID SUTURE

Reason

Smith & Nephew, Inc. has initiated a field action to voluntarily remove certain lots from the group of Suture-Based Repair Systems. Issue identified in the product packaging process may result in an improper or incomplete seal of the pouch surrounding the sterile product.

Affected products

A. OSTEORAPTOR 2.9 SUTURE ANCHOR W/TWO ULTRABRAID SUTURES

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 72201995
  • 72201996
  • 72202165
Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


B. OSTEORAPTOR 2.9 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72201994

Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


C. OSTEORAPTOR 2.3 SUTURE ANCHOR W/ONE ULTRABRAID SUTURE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 72201991
  • 72201992
  • 72201993
Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


D. TWINFIX AB 6.5 SUTURE ANCHOR WITH NEEDLES

Lot or serial number
  • 2025178
  • 2025362
  • 2040057
Model or catalog number

7210710

Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


E. FAST-FIX AB CURVED NEEDLE MENISCAL REPAIR SYSTEM WITH SUTURE BAR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72201494

Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


F. RAPTORMITE 3.7 AB W/NEEDLES AND TWO #0 ULTRABRAID, WHITE AND COBRAID BLUE

Lot or serial number
  • 2025354
  • 2031116
  • 2040066
  • 2040702
  • 2042557
  • 2049638
  • 2053749
  • 2055239
Model or catalog number

72201805

Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


G. TWINFIX ULTRA HA SUTURE ANCHOR W/THREE ULTRABRAID SUTURES

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 72202602
  • 72202608
  • 72202626
Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


H. OSTERAPTOR CURVED 2.3 SUTURE ANCHOR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

72203290

Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


I. TWINFIX ULTRA HA 4.5MM SUTURE ANCHOR W/SUTURES AND NEEDLES

Lot or serial number
  • 2027487
  • 2031136
  • 2033257
  • 2034471
  • 2038440
  • 2050957
  • 2053792
  • 2056056
Model or catalog number

72202612

Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


J. TWINFIX ULTRA HA 5.5MM SUTURE ANCHOR W/SUTURES AND NEEDLES

Lot or serial number
  • 2027489
  • 2056058
  • 2025074
  • 2031006
  • 2042572
  • 2052109
Model or catalog number

72202616

Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


K. HEALICOIL REGENESORB SUTURE ANCHOR

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 72203704
  • 72203706
  • 72203707
Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES


L. HEALICOIL REGENESORB SUTURE ANCHOR WITH ONE ULTRATAPE AND ONE ULTRABRAID SUTURE

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number
  • 72203697
  • 72203705
  • 72203708
  • 72203801
Companies
Manufacturer

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover

01810

Massachusetts

UNITED STATES