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U.S. Department of Health and Human Services

Class 2 Device Recall TMJ Concepts

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  Class 2 Device Recall TMJ Concepts see related information
Date Initiated by Firm December 06, 2022
Date Posted March 08, 2023
Recall Status1 Open3, Classified
Recall Number Z-1234-2023
Recall Event ID 91479
PMA Number P980052 
Product Classification Joint, temporomandibular, implant - Product Code LZD
Product Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
Code Information TMJ Reconstruction Prosthesis, Catalog #2208151054, Lot Number W67725 UDI/DI: B004YYMMDDNNNNLM0
Recalling Firm/
Manufacturer		 Stryker Leibinger GmbH & Co. KG
Botzinger Str. 41
Freiburg Im Breisgau Germany
For Additional Information Contact Christoph Ongom-Along
+4976145120 Ext. 0
Manufacturer Reason
for Recall		 Device was shipped without having regulatory approval.
FDA Determined
Cause 2		 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 in Commerce 1 unit
Distribution Distribution of one unit only to a single customer in MA (USA)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = LZD and Original Applicant = TMJ CONCEPTS
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