Device product
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x30 mm Catalog Number: 18965030S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Z-2381-2020
Product summary
- Firm
- Stryker GmbH
- Event
- Event 85681
- Status
- Terminated
- Classification
- Class II
- Quantity
- US 46; OUS 314
- Official record key
device-enforcement:Z-2381-2020
Official wording
Reason: Seal integrity of the blister pack may be compromised and sterility cannot be assured
Code information: Lot Number: K0207B0, K02C1A8, K02C1A9, K0302E4
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