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:

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