Recall Z-2219-2024 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker GmbH
Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.
| Date | Jun 27, 2024 (initiated May 9, 2024) |
| Status | Open, Classified |
| Reason | The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly. |
| Root cause | Process change control |
| Action | The recalling firm issued letters dated 5/9/2024 on 5/9/2024 and 5/11/2024 via email to sales reps and distributors and via FedEx ground to hospitals. The letter described the product, the issue, and potential risks. The consignees instructions were: (1) Immediately check your inventory to locate the affected product listed on the Business Reply Form, remove the product from its point of use, and isolate it to prevent accidental use; (2) Sign and return the enclosed Business Reply Form by email by 5/15/2024 to confirm receipt of the notification/documenting product disposition: (3) Upon rec |
| Quantity | 39 devices |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.