Recall Z-2566-2014 ยท LZD Joint, Temporomandibular, Implant
Biomet Microfixation, LLC
Biomet Microfixation Temporomandibular Joint (TMJ) Patient Matched Left Fossa Part# CP751506 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 a glenoid fossa components. Both components are
| Date | Sep 2, 2014 (initiated Sep 20, 2013) |
| Status | Terminated |
| Reason | Product mix occurred prior to final package and labeling process. |
| Root cause | Mixed-up of materials/components |
| Action | Biomet Microfixation, Inc. sent an Urgent Medical Device Field Notice dated September 20, 2013 to its customer. The customer was instructed to: 1) Immedicately quarantine the device. 2) Discontinue use and return to Biomet Microfixation. 3) If the product was further distributed, the letter must be forwarded to the firm's customers. 4) A replacement device will be shipped priority upon completion. Questions related to this notice should be directed to 904-741-9448 or 904-239-6671. For questions regarding this recall call 904-741-4400. |
| Quantity | 1 |
| Distribution | Worldwide Distribution to Denmark only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.