Reported Oct 2, 2024 · Ongoing
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone…
TMJ Solutions Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TMJ Solutions Inc · 6059 King Dr · Ventura, CA · 93003-7607
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
GHG010 | consisting of the following components |
CHG010AM | Anatomical Bone Model, Accessory |
CHG010RF | Glenoid Fossa Component, Right |
CHG010RM | Mandibular Component, Right. |
- Lot codes and dates
- Order # 101432374 - Lot # 2403081022
- UDI(01)07613327627800/(01)07613327625551
- Amount recalled
- 1
Where it was sold
- Nationwide
- MN
Why it was recalled
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
This product could cause temporary or reversible health problems — stop using it.
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