Recall Z-1191-2023 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker GmbH
stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone fragments/segments in a correct anatomical position until reliable bone consolidation is achieved
| Date | Mar 1, 2023 (initiated Feb 7, 2023) |
| Status | Open, Classified |
| Reason | Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring fixation cannot be locked between 0- 50mm of the threaded rod. |
| Root cause | Process change control |
| Action | The firm issue an URGENT MEDICAL DEVICE RECALLL its consignees by letter on 02/07/2023. The notice explained the product and the issue and requested the following actions be taken: 1. Check inventory for affected product and remove from use 2, Sign and return the enclosed Business Reply Form by email to fieldaction@stryker.com to confirm receipt of this notification/documenting product disposition. Stryker will will contact you to arrange for the return of the affected device(s) 3. Spread awareness of this communication internally until all required actions have been completed within your |
| Quantity | 488 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153377 | Hoffmann LRF (Limb Reconstruction Frame) System Stryker GmbH, Apr 11, 2016 |