TMJ Solutions Inc: Medical Device Recall in 2024 - (Recall #: Z-3264-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 24, 2024

Date Posted: October 2, 2024

Recall Number: Z-3264-2024

Event ID: 95139

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1

Code Information:

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

Distribution Pattern:

US Nationwide distribution in the state of MN.

Voluntary or Mandated:

Voluntary: Firm initiated