Recall Z-0488-2026 ยท LZD Joint, Temporomandibular, Implant
TMJ Solutions Inc
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
| Date | Nov 14, 2025 (initiated Oct 13, 2025) |
| Status | Open, Classified |
| Reason | Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position. |
| Root cause | Process control |
| Action | On February 25, 2026 Stryker (TMJ Solutions) issued a " Urgent: Medical Device Recall" Expansion notification to additional, affected consignees. Initial notification and previous expansion was issued on September 30, 2025 and December 4, 2025. TMJ Solutions asked consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product (Attachment B). Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form or use the QR Co |
| Quantity | 63 units |
| Distribution | US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.