Recall Z-0102-2008 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Biomet, Inc.
Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581
| Date | Oct 27, 2007 (initiated Aug 9, 2007) |
| Status | Terminated |
| Reason | Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended. |
| Root cause | Process control |
| Action | The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts |
| Quantity | 5 |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.