FDA Recall
Terminated
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
Recall: Z-2475-2015
·
Initiated July 22, 2015
Recall
- Recall Number
- Z-2475-2015
- Event Number
- 71834
- Firm
- Synthes (USA) Products LLC
- FEI Number
- 3008812560
- Product Code
- JDQ
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- July 22, 2015
- Posted
- August 27, 2015
- Terminated
- August 18, 2016
- Address
- 1301 Goshen Pkwy, West Chester, PA, 19380-5986
Description
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
Reason
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
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.
Distribution
Nationwide and internationally to Canada.
Quantity
451