Recall Z-1626-2015 ยท HWC Screw, Fixation, Bone
Wright Medical Technology, Inc.
PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
| Date | May 18, 2015 (initiated Apr 16, 2015) |
| Status | Terminated |
| Reason | The term DORSAL was laser etched on the incorrect side on some of the angled handles. |
| Root cause | Process control |
| Action | Wright sent an Urgent Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product, send it back to Wright Medical as soon as possible. Contact Customers Service at 901-867-4575 for return instructions and replacement inventory. Customers were instructed to complete the attached response immediately, confirming their receipt of this notice and the status of any product(s) on had, and return a copy by email |
| Quantity | 124 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.