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Open, Classified

Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis

FDA Recall Z-1234-2023 · Posted 2023-03-08

Recalling FirmStryker Leibinger GmbH & Co. KG
Recall StatusOpen, Classified
Product CodeLZD
Date Initiated2022-12-06
Product Quantity1 unit

Reason for Recall

Device was shipped without having regulatory approval.

Firm 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].

Root Cause

No Marketing Application

Distribution Pattern

Distribution of one unit only to a single customer in MA (USA)

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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