Z-3264-2024Class II

Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM...

Name: Z-3264-2024 Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM...
Creator: TMJ Solutions Inc
Published: 2024-07-24
License: https://open.fda.gov/license/

TMJ Solutions, LLC / initiated 2024-07-24 / Open, Classified / root cause: sterility

FDA source

TMJ Solutions Inc began a recall of Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid... on 2024-07-24. FDA classified it as Class II and gives the reason as "Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-3264-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-07-24
Posted: 2024-09-26
Recalling firm: TMJ Solutions, LLC
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.
Product code: LZD Joint, Temporomandibular, Implant
Reason for recall: Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Root cause tag: sterility
FDA root cause: Mixed-up of materials/components
Action: On May 29, 2024, TMJ Solutions Inc. spoke with consignees concerning the recall device.
Quantity in commerce: 1
Distribution: US Nationwide distribution in the state of MN.
Product codes and lots: Order # 101432374 - Lot # 2403081022, UDI: (01)07613327627800/(01)07613327625551

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3264-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3264-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26

Product code LZD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)