Recall Z-1526-2018 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker GmbH
Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.
| Date | Mar 12, 2018 |
| Status | Terminated |
| Reason | The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling |
| Root cause | Labeling mix-ups |
| Action | Stryker sent an Urgent Product Recall letter dated March 12, 2018, to all affected customers. . Product will be returned to the manufacturer for disposition. Non-responding consignees will be attempted to be contacted a minimum of three times in total. Returned product will be quarantined and returned to the manufacturer. Product will be returned to the manufacturer for disposition. For further questions, please call (201) 831-5272. |
| Quantity | 18 |
| Distribution | USA (nationwide) Distribution |
| 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 |