T2 Tibial Nail System - Locking Screws, Fully Threaded, End Caps & S2 Screws, Locking Screw, Fully Threaded, Sterile (2020-04-30)
- Starting date:
- April 30, 2020
- Posting date:
- May 15, 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-73107
Last updated: 2020-05-15
Affected Products
- T2 Tibial Nail System - Locking Screws, Fully Threaded
- T2 Tibial Nail System - End Caps
- S2 Screws, Locking Screw, Fully Threaded, Sterile
Reason
Stryker corporation investigated a nonconformance with a supplier. The manufacturer found that the coating of the sealing lids for the sterile packaging was defective for a part of a certain supplier batch. It cannot be completely excluded that parts of it have been put on the market. The seal integrity of the blister pack may be compromised. Stryker Trauma GMBH, Trauma and Extremities Division will recall all unused items from the identified lots.
Affected products
A. T2 Tibial Nail System - Locking Screws, Fully Threaded
Lot or serial number
- K0207B0
- K030EE8
- K030F1D
- K030F1E
- K031B70
Model or catalog number
- 1896-5030S
- 1896-5035S
- 1896-5045S
- 1896-5050S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY
B. T2 Tibial Nail System - End Caps
Lot or serial number
- K020795
- K020796
Model or catalog number
- 1822-0010S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY
C. S2 Screws, Locking Screw, Fully Threaded, Sterile
Lot or serial number
- K0386FB
Model or catalog number
- 1796-5035S
Companies
- Manufacturer
-
Stryker Trauma GMBH
Prof.-Kuntscher-Str.1-5
Schoenkirchen
24232
GERMANY