Home / Recalls / TMJ Solutions Inc / Z-3264-2024

Z-3264-2024 Class II Ongoing

Recalled by TMJ Solutions Inc — Ventura, CA

Recall Details

Product Type: Devices
Report Date: October 2, 2024
Initiation Date: July 24, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1

Product Description

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

Distribution Pattern

US Nationwide distribution in the state of MN.

Code Information

Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551