Reported Nov 6, 2013 · Terminated
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the…
Synthes USA HQ, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
- Lot codes and dates
- Part No.: 03.501.080
- with multiple lot numbers
378349237839133788496382233275167287606881763521876531787659168766608576719347679825768924476943777700691770515777205997738572773857377404987742713776749777976487803768780688178186777818682782167278270887831855783360678584078068078
- Amount recalled
- 319
Where it was sold
- Nationwide
Why it was recalled
When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
This product could cause temporary or reversible health problems — stop using it.
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