FDA Device recall Z-3264-2024
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF:…
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF:… by Tmj Solutions, citing patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3264-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-24 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tmj Solutions |
| Distribution | US |
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
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Identifiers
| code_info | Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3264-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.