Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Brand
Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany
Lot Codes / Batch Numbers
TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
Products Sold
TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
Stryker Leibinger GmbH & Co. KG Botzinger Str. 41 Freiburg Im Breisgau Germany is recalling Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis due to Device was shipped without having regulatory approval.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device was shipped without having regulatory approval.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, MA
Page updated: Jan 10, 2026