Device product
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Z-2219-2024
Product summary
- Firm
- Stryker GmbH
- Event
- Event 94721
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 39 devices
- Official record key
device-enforcement:Z-2219-2024
Official wording
Reason: The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
Code information: Lot #J43995, UDI-DI 07613252611035.
Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.
Derived failure modes
-
Unknown
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.