T2 TIBIAL NAIL SYSTEM- NAIL INSERTION SLEEVE ELASTIC (2021-05-20)
- Starting date:
- May 20, 2021
- Posting date:
- May 26, 2021
- 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-75671
Last updated:
2021-05-26
Affected Products
T2 TIBIAL NAIL SYSTEM- NAIL INSERTION SLEEVE ELASTIC
Reason
Stryker Trauma GmbH (Trauma & Extremities Division) determined through its quality system (product complaints received December 2020) that two specific lots of T2 Nail Insertion Sleeve instrument, referenced in the table above, contain devices that have a different inner diameter than the diameter specified on the outer box label. Specifically, the products in: (i) lot number K03CC50 contained products with an inner diameter that was 2mm smaller than the label indicates; and (ii) lot number K03CC4F contained products with an inner diameter that was 2mm larger than the label indicates.
Affected products
T2 TIBIAL NAIL SYSTEM- NAIL INSERTION SLEEVE ELASTIC
Lot or serial number
- K03CC4F
- K03CC50
Model or catalog number
- 1806-1406S
- 1806-1407S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY