FDA Enforcement
Class II
Terminated
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Recall: Z-2374-2020
·
Reported June 24, 2020
Enforcement
- Recall Number
- Z-2374-2020
- Event ID
- 85681
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 24, 2020
- Initiation Date
- May 7, 2020
- Classification Date
- June 16, 2020
- Termination Date
- September 21, 2023
- Address
- Bohnackerweg 1, Selzach, N/A, Switzerland
Description
Stryker Compression Screw, Advanced T2 Tibia Catalog Number: 18220001S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Reason
Seal integrity of the blister pack may be compromised and sterility cannot be assured
Code Info
Lot Number: K020791
Distribution
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.
Quantity
26 OUS