Recall Z-1982-2012 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral p
| Date | Jul 10, 2012 (initiated Dec 29, 2011) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has become aware of the potential for cracking of the PMMA coating on their PM COCR Hip Stem product. |
| Root cause | Employee error |
| Action | Stryker Orthopaedics sent an Urgent Product Recall letter dated January 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact their Stryker Sales Representative to arrange for return of any affected product. Customers were also asked to fax back the attached Product Recall Acknowledgement Form as soon as possible to 201-831-6069. For any questions customers should call 201-972-2100. For any questions regarding this recall please call 201-831-5970. |
| Quantity | 16,913 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K936127 | HOWMEDICA PREMIUM FEMORAL COMPONENT Howmedica, Inc., Oct 26, 1994 |