Recall Z-0656-2013 ยท MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Stryker Howmedica Osteonics Corp.
Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
| Date | Jan 8, 2013 (initiated Oct 23, 2012) |
| Status | Terminated |
| Reason | Stryker has received a report that single size 3.5 stem was packaged as size 2.5 stem resulting in a possible product mix. |
| Root cause | Labeling mix-ups |
| Action | Stryker sent "Urgent Medical Device Recall Notification" letters and product accountability forms via Fed Ex with return receipt on 10/23/12 to branches/agencies and to hospitals and physicians on 10/24/12. The letter described the issue and provided recommended actions to mitigate the risk. Customers can call (201) 972-2100 if questions. |
| Quantity | 6021-2530- four units; 6021-3535- |
| Distribution | Nationwide distribution, including the states of NY, NJ, CA and FL. |
| 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 |