Recall Z-0823-2012 ยท MPL Mandibular Condyle Prosthesis
Biomet Microfixation, Inc.
The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular Joint (TMJ) Replacement System used to functionally reconstruct a diseased and/or damaged temporomandibular joint. The component is labeled in part: "REF: 24-6646***TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO, TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Dri
| Date | Jan 20, 2012 (initiated Apr 7, 2010) |
| Status | Terminated |
| Reason | Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part # 24-6646, 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse, a lot of 24-6646 being etched and labeled as 24-6546. |
| Root cause | Employee error |
| Action | Biomet Microfixation Inc sent an URGENT-Medical Device Recall notice to all consignees. The letter informs the customers to discontinue use of the items and return them to Biomet Microfixation.They also ask all customers to complete the inventory reconciliation sheet and return it by fax to the Global Complaint Coordinator. The letter also states that if the product was further distributed, the letter must be forwarded on to the firm's customers. For questions call 1-800-874-7711 or 904-741-4400, ext 468. |
| Quantity | 2 pieces |
| Distribution | Worldwide Distribution - USA (nationwide) in the state of Florida and in the countries Germany and Guatemala. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.