Device product
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x45 mm Catalog Number: 18965045S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Z-2385-2020
Product summary
- Firm
- Stryker GmbH
- Event
- Event 85681
- Status
- Terminated
- Classification
- Class II
- Quantity
- US:127; OUS 454
- Official record key
device-enforcement:Z-2385-2020
Official wording
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Code information: Lot Number: K02C1BB, K03033E, K030342, K03035D, K030F17, K030F1D, K031B6E, K031B70, K0328A5
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Netherlands, Poland, South Africa, Spain, Sweden, Switzerland, United Kingdom. Updated 7/21/20: Portugal, Denmark, Finland, Norway, Ireland, and Luxembourg.
Derived failure modes
-
Sterility assurance
sterility cannot be assured