Recall Z-3264-2024 ยท LZD Joint, Temporomandibular, Implant
TMJ Solutions Inc
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
| Date | Sep 26, 2024 (initiated Jul 24, 2024) |
| Status | Open, Classified |
| Reason | Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO |
| Root cause | Mixed-up of materials/components |
| Action | On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device. |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of MN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.