TMJ Solutions Inc 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. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
TMJ Solutions Inc
Lot Codes / Batch Numbers
Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
Products Sold
Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551
TMJ Solutions Inc is recalling Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, due to Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Recommended Action
Per FDA guidance
On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026