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.

This recall is currently active, issued September 26, 2024. It was issued by Tmj Solutions Inc.

Company: Tmj Solutions Inc
Recall Initiated: July 24, 2024
Posted: September 26, 2024
Recall Number: Z-3264-2024
Quantity: 1
Firm Location: Ventura, CA
Official Source: View on FDA website ↗

Reason for Recall

Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO

Distribution

US Nationwide distribution in the state of MN.

Lot / Code Info

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

Root Cause

Mixed-up of materials/components

Action Taken

On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device.