Recall Z-2524-2026 ยท LZD Joint, Temporomandibular, Implant
TMJ Solutions Inc
TMJ Bilateral Implants, REF: CHG020
| Date | Jun 22, 2026 (initiated Feb 11, 2026) |
| Status | Open, Classified |
| Reason | Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite. |
| Root cause | Process control |
| Action | On 2/11/2026, the customer was contacted and verbally informed of the recall. On 4/23/2026, a recall notice was sent to the customer asking them to take the following action: 1) Inform all appropriate members of your organization who need to be made aware of this action. 2) The affected product is already implanted. Following explantation, during revision surgery, the explanted device shall be returned to the firm's sales representative. 3) Complete and return the Business Reply Form (BRF) via email to cmf-pfa@stryker.com Please contact the firm's quality department cmf-pfa@stryker.com wit |
| Quantity | 1 |
| Distribution | US Nationwide distribution in the state of MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.