Recall Z-2675-2018 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Howmedica Osteonics Corp.
Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
| Date | Oct 24, 2017 |
| Status | Terminated |
| Reason | Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. |
| Root cause | Under Investigation by firm |
| Action | On October 27, 2017 an URGENT MEDICAL RECALL NOTIFICATION was issued to customers titled Product Field Action PR 1642784. The letter requests that recipients notify all necessary individuals within their organization of the recall and that a Stryker trauma representative will collect any affected product from the customer location. Questions or concerns can be directed to 201-831-6693 |
| Quantity | 191 |
| Distribution | Distribution US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062898 | SBI LATERAL RHEAD IMPLANT Small Bone Innovations, Inc., Nov 13, 2006 |