FDA Enforcement
Class II
Terminated
Stryker Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
Recall: Z-2384-2020
·
Reported June 24, 2020
Enforcement
- Recall Number
- Z-2384-2020
- 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 Locking Screw, Fully Threaded T2 Tibia ¿5x40 mm Catalog Number: 18965040S - 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: K0207B3, K031B6B, K031B6C, K033439
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
OUS 400