Z-2219-2024 Class II Ongoing
FDA device recall Z-2219-2024 was initiated by Stryker GmbH on May 9, 2024 and is designated Class II. Reason for recall: The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. The recall status is ongoing. Affected quantity: 39 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2024
- Initiation Date
- May 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 39 devices
Product Description
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
Reason for Recall
The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.
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.
Code Information
Lot #J43995, UDI-DI 07613252611035.