Recall Z-1677-2012 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The Restoration HA cementless Hip System is designed to address the problems of revision surgery where extensive fixation both distally and proximally is required for support of the prosthesis. A comprehensive size range mates a variety of proximal cross sections a
| Date | May 29, 2012 (initiated Oct 27, 2011) |
| Status | Terminated |
| Reason | An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8. |
| Root cause | Error in labeling |
| Action | Stryker sent an "URGENT PRODUCT RECALL" letter dated October 27, 2011 and October 28, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs the customers to return the product to the firm. An Acknowledgement Form was included for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall. |
| Quantity | 31 Units |
| Distribution | Nationwide Distribution and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951671 | OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES Osteonics Corp., Sep 6, 1995 |