Recall Z-0695-2013 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker Howmedica Osteonics Corp.
Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
| Date | Jan 17, 2013 (initiated Oct 25, 2012) |
| Status | Terminated |
| Reason | Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients. |
| Root cause | Device Design |
| Action | Stryker sent "Urgent Medical Device Removal" notification letters and acknowledgement forms dated 10/25/2012 via Fed Ex to Branches/Agencies with return receipt. Stryker sent notification letters/acknowledgement forms dated 10/26/202 via Fed Ex to Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letters described the device issue and provided recommended actions. Questions were directed to Stryker Customer Service. |
| Quantity | 476 units |
| Distribution | Nationwide Distribution, including the states of PA, OH, NY, CA and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113327 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM Stryker Corp., Mar 29, 2012 |