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
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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
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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.
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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 |
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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.
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PMA Database | PMAs with Product Code = LZD
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