Z-0488-2026Class I

TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only

Name: Z-0488-2026 TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Creator: TMJ Solutions Inc
Published: 2025-10-13
License: https://open.fda.gov/license/

TMJ Solutions, LLC / initiated 2025-10-13 / Open, Classified / root cause: manufacturing process

FDA source

TMJ Solutions Inc began a recall of TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only on 2025-10-13. FDA classified it as Class I and gives the reason as "Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0488-2026
Classification: Class I
Status: Open, Classified
Initiated: 2025-10-13
Posted: 2025-11-14
Recalling firm: TMJ Solutions, LLC
Product: TMJ Bilateral Implant REF: CHG020 Sterile EO, Rx Only
Product code: LZD Joint, Temporomandibular, Implant
Reason for recall: Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On February 25, 2026 Stryker (TMJ Solutions) issued a " Urgent: Medical Device Recall" Expansion notification to additional, affected consignees. Initial notification and previous expansion was issued on September 30, 2025 and December 4, 2025. TMJ Solutions asked consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product (Attachment B). Segregate the affected products, quarantine and discontinue use. 3. Please complete the Business Reply Form or use the QR Code on Attachment A. Response is required. a. If you have indicated that product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility .
Quantity in commerce: 63 units
Distribution: US: IL, OR, MS, TX, OK, UT, MA, MD, NY, PA, VA, FL, CA, MN, GA OUS: Canada, Spain, Brazil,
Product codes and lots: UDI: 07613327626551,07613327626568,07613327626575,07613327626605,07613327627749 07613327627848/ Lot #s: 2410301062 2306091054 2312121078 2401181023 2401231058 2403191046 2404291064 2405021079 2407221023 2407241032 2408081047 2408131037 2408161043 2409031033 2409241016 2410011097 2410071065 2410091014 2410111030 2410291062 2411111012 2411121044 2411201015 2412061031 2412121062 2412201009 2501021011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0488-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0488-2026	Class I	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-14

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)