Recall Z-2160-2017 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker Howmedica Osteonics Corp.
Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, NDC (01)07613327131475(10)V07241 Product Usage: Intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, and bone and soft tissue reconstruction in pediatric patients and adults.
| Date | Apr 26, 2017 |
| Status | Terminated |
| Reason | Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety Clip - Bone Transport Strut because there is a potential for loosening of the safety clips from the intended position on the Quick Release mechanism of the Transport Struts. |
| Root cause | Device Design |
| Action | Stryker sent via FedEx an "Urgent Medical Device Recall Notification and Business Reply Form" dated April 26, 2017 to their affected customers. For questions call (201) 831-6693. |
| Quantity | 437 units |
| Distribution | US Nationwide distribution in the states of CA, FL, MD and VT |
| 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 |