Recall Z-2427-2015 ยท KXE Prosthesis, Wrist, Hemi-, Ulnar
Stryker Howmedica Osteonics Corp.
uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
| Date | Aug 20, 2015 (initiated Jun 24, 2015) |
| Status | Terminated |
| Reason | Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. |
| Root cause | Packaging change control |
| Action | Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager. |
| Quantity | 16992 total |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061146 | SBI ULNAR HEAD IMPLANT Small Bone Innovations, Inc., Jul 19, 2006 |