Synthes 3.0 MM TI Cannulated Screw Instrument and Implant Set
FDA Recall Z-2265-2014 · Posted 2014-08-19
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Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2014-06-30
Date Terminated2015-12-18
Product Quantity4
Reason for Recall
A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic.
Firm Action
An Urgent Field Safety Notification, dated July 21, 2014, was sent to surgeons explaining the product, problem, and action to be taken with regard to routine post-operative follow-up on patients exposed to the affected product. Questions or concerns should be directed to Leonie Rynn at 610-719-5408 or [email protected].
Root Cause
Employee error
Distribution Pattern
Distributed in the states of WI and MI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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