Recall Z-0075-2012 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Total Hip Joint Replacement Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #3 Accolade TMZF Plus 127 Neck Angle V40 Hip Stem #5 Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 A subsidiary of Stryker Corp. Stryker France ZAC Satolos Green Pusignan Av de Staolas Green 69881 Metziae Cedex France The TMZF Press Fit HA Stem and TMZF Press Fit Plus HA Stem are intended for the re
| Date | Oct 20, 2011 (initiated Jul 14, 2011) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has become aware that a size 3 Accolade stem was in a box labeled as a size 5 Accolade stem. |
| Root cause | Mixed-up of materials/components |
| Action | Stryker Orthopaedics sent an "URGENT: PRODUCT RECALL" letter dated July 14, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and return an attached Product Recall Acknowledgment Form via fax to 201-831-6069. Additionally, information is provided for customers to return the affected products. Please contact the Divisional Regulatory Compliance Manager at 201-972-2100 for questions regarding this notice. |
| Quantity | 21 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994366 | TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM Howmedica Osteonics Corp., Mar 16, 2000 |