FDAClass IIOctober 2, 2024

Stryker TMJ Unilateral Implant recall

Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF…

Why was Stryker TMJ Unilateral Implant recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF…
Recalling firm
TMJ Solutions Inc
Quantity
1
Distribution
US Nationwide distribution in the state of MN.
Recall date
October 2, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls