Stryker TMJ Unilateral Implant — Class II medical device recall Z-3264-2024
Ongoing recall by TMJ Solutions Inc, reported 2024-10-02, distributed nationwide. Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
| Recall number | Z-3264-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | TMJ Solutions Inc, Ventura, CA, United States |
| Recall initiated | 2024-07-24 |
| Classified | 2024-09-26 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 07613327627800 |
| Lot numbers | 2403081022 |
| Model numbers | CHG010AM, CHG010RF, CHG010RM, GHG010 |
Product
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.
Reason for recall
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
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-3264-2024. 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.