FDA Medical Device Recalls (openFDA)
Stryker Leibinger GmbH & Co. KG: Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
- Recall number
- Z-1234-2023
- Recalling firm
- Stryker Leibinger GmbH & Co. KG
- Product
- Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
- Status
- Open, Classified
- Initiated
- 2022-12-06
- Posted
- 2023-03-08
- Terminated
- not on file
- Reason
- Device was shipped without having regulatory approval.
- 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 CMF-custserv@stryker.com.
- Quantity
- 1 unit
- Distribution
- Distribution of one unit only to a single customer in MA (USA)
- Lot, serial or model codes
- TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
- 510(k) numbers
- not on file
- PMA numbers
- P980052
- Product code
- LZD
- Firm FEI
- 3002821504
- Firm city
- Freiburg Im Breisgau
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28