Recall Z-1444-2018 ยท LZD Joint, Temporomandibular, Implant
TMJ Solutions Inc
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the temporomandibular joint. It is indicated for patients with one or more of the following conditions: Inflammatory arthritis involving the
| Date | Apr 19, 2018 (initiated Mar 12, 2018) |
| Status | Terminated |
| Reason | This device was mislabeled and is not the correct component for this patient. |
| Root cause | Error in labeling |
| Action | TMJ Concepts sent an Medical Device Recall Communication letter dated March 12, 2018. INSTRUCTIONS: The implants for this case should not be used and should be immediately quarantined. We request that you return the entire case (the anatomical bone model together with both the fossa and mandibular components) to us by FedEx Priority Overnight Delivery. Any bone screws and drills that were provided with the shipment can be retained at your hospital and do not need to be returned. For further questions, please call (805) 650-3391. |
| Quantity | 1 |
| Distribution | US Distribution to GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.