Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
FDA Recall Z-2475-2015 · Posted 2015-08-27
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeJDQ
Date Initiated2015-07-22
Date Terminated2016-08-18
Product Quantity451
Reason for Recall
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
Firm Action
Urgent recall notification letters, dated July 22, 2015 were sent to end users and consultants to inform them of the issue, the associated risks, and provided instructions to return affected devices along with the response form.
Root Cause
Device Design
Distribution Pattern
Nationwide and internationally to Canada.
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.