Recall Z-1668-2010 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Biomet, Inc.
Mallory Head Calcar Femoral, 34 mm resection/porous coated, 13.0 x 170 mm,, Sterile, REF 11-104904, Biomet Orthopaedics, Warsaw, IN. Implant device intended for use in femoral revision surgery.
| Date | May 26, 2010 (initiated Mar 10, 2010) |
| Status | Terminated |
| Reason | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. |
| Root cause | Process change control |
| Action | Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated March 10, 2010. The letter went to distributors and users of the recalled device. The letter instructed the consignees to locate the recalled product and return the product to the firm. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983, Monday through Friday, 8:00 AM to 5:00 PM. |
| Quantity | 6 |
| Distribution | Worldwide Distribution -- United States (OH, IN, FL, KY, NV and CA), Mexico, Chile, China, Japan and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031693 | MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA Biomet, Inc., Aug 6, 2003 |