TMJ Bilateral Implant REF: CHG020 Sterile EO — Class I medical device recall Z-0488-2026
Ongoing recall by TMJ Solutions Inc, reported 2025-11-26, distributed in CA, FL, GA, IL, MA, MD, MN, MS…. Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
| Recall number | Z-0488-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TMJ Solutions Inc, Ventura, CA, United States |
| Recall initiated | 2025-10-13 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | CA, FL, GA, IL, MA, MD, MN, MS, NY, OK, OR, PA, TX, UT, VA |
| Countries outside the US | BR, CA, ES |
| Quantity | 63 units |
| UPC / GTIN / UDI-DI | 07613327626551, 07613327626568, 07613327626575, 07613327626605, 07613327627749, 07613327627848 |
| Lot numbers | 2306091054, 2312121078, 2401181023, 2401231058, 2403191046, 2404291064, 2405021079, 2407221023, 2407241032, 2408081047, 2408131037, 2408161043, 2409031033, 2409241016, 2410011097, 2410071065, 2410091014, 2410111030, 2410291062, 2410301062, 2411111012, 2411121044, 2411201015, 2412061031, 2412121062, 2412201009, 2501021011 |
| Model numbers | CHG020 |
Product
TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Reason for recall
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0488-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.