Recall Z-0822-2012
Biomet Microfixation, Inc. · initiated April 7, 2010
Product
The 45mm Left Standard 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: 24-6546***TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT***QTY 00001***45MM / 7 HOLE CO-CR-MO, TI-6AL-4V ALLOY***BIOMET MICROFIXATION 1520 Tradeport Drive Jacksonville, FL 32218 USA www.biometmicrofixation.com*** Product Usage: The Total Temporomandibular Joint (TMJ) Replacement System is implanted in the jaw to functionally reconstruct a diseased and/or damaged temporomandibular joint. The Total TMJ Replacement System is a two-component system comprised of mandibular condyle and glenoid fossa components. Both components are available in multiple sizes as right and left side specific designs and are attached to bone by screws. Mandibular (Condylar) Prosthesis- The prosthesis is designed to replace the articular surface of the mandibular condyle. The mandibular prosthesis is offered in 3 different sizes: 45mm, 50mm, and 55mm, designated left and right. The mandibular prosthesis is offered in 3 styles:Standard, Offset, and Narrow, to fit a diverse range of mandibular sizes and shapes. The mandibular prosthesis is made of Cobalt Chromium Alloy. The under-surface of the prosthesis is coated with titanium plasma spray for increased bony integration to the mandibular prosthesis.
Codes / lots: Product Part # 24-6546, lot # 082800
Reason for recall
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.
FDA-determined cause: Employee error
Action taken
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.
Details
- Recall number
- Z-0822-2012
- Initiated
- April 7, 2010
- Posted by FDA
- January 20, 2012
- Terminated
- February 6, 2012
- Product code
- MPL – Mandibular Condyle Prosthesis
- Quantity
- 2 pieces
- Distribution
- Worldwide Distribution - USA (nationwide) in the state of Florida and in the countries Germany and Guatemala.
- Recalling firm
- Biomet Microfixation, Inc., Jacksonville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0823-2012 | The 45mm Left Standard Offset Mandible is one component in the Total Temporomandibular…Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part #… | 04/07/2010Terminated |