Z-1234-2023Class II

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

Name: Z-1234-2023 Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Creator: Stryker Leibinger GmbH & Co. KG
Published: 2022-12-06
License: https://open.fda.gov/license/

Stryker Leibinger GmbH & Co. KG / initiated 2022-12-06 / Open, Classified

FDA source

Stryker Leibinger GmbH & Co. KG began a recall of Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis on 2022-12-06. FDA classified it as Class II and gives the reason as "Device was shipped without having regulatory approval". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1234-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-06
Posted: 2023-03-08
Recalling firm: Stryker Leibinger GmbH & Co. KG
Product: Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Product code: LZD Joint, Temporomandibular, Implant
Reason for recall: Device was shipped without having regulatory approval.
FDA root cause: No Marketing Application
Action: Stryker sent an Urgent Medical Device Recall letter dated December 21, 2022, to affected customers. The letter identified the affected product, problem and actions to be taken. This event is isolated to a single patient-specific product that at the time of recall notification, has already been retrieved by the recalling firm. F questions or concerns, contact Customer Service +1 800 962-6558. Please confirm the acknowledgement of this notification to [email protected].
Quantity in commerce: 1 unit
Distribution: Distribution of one unit only to a single customer in MA (USA)
Product codes and lots: TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1234-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1234-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-07

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)