Formula Resector Cutter, Formula Aggressive Plus Cutter and Formula Barrel Bur (2018-08-08)
- Starting date:
- August 8, 2018
- Posting date:
- August 17, 2018
- 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-67460
Affected products
- Formula Resector Cutter
- Formula Aggressive Plus Cutter
- Formula Barrel Bur
Reason
Stryker's sustainability solutions division has determined that affected lots of reprocessed arthroscopic shavers may display the incorrect catalog number and speed settings when connected to the generator, require manual mode for use on core generators, or display an error message on crossfire 1 and 2 generators which does not allow the device to be used.
Affected products
A. Formula Resector Cutter
Lot or serial number
8082746
Model or catalog number
375-542-000
Companies
- Manufacturer
-
Stryker Sustainability Solutions, Inc.
1810 West Drake Dr.
Tempe
85283
Arizona
UNITED STATES
B. Formula Aggressive Plus Cutter
Lot or serial number
- 8069955
- 8181408
- 8220563
Model or catalog number
375-544-000
Companies
- Manufacturer
-
Stryker Sustainability Solutions, Inc.
1810 West Drake Dr.
Tempe
85283
Arizona
UNITED STATES
C. Formula Barrel Bur
Lot or serial number
- 8121786
- 8273275
Model or catalog number
375-941-012
Companies
- Manufacturer
-
Stryker Sustainability Solutions, Inc.
1810 West Drake Dr.
Tempe
85283
Arizona
UNITED STATES