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
Reported: September 2, 2015 Initiated: July 22, 2015 #Z-2475-2015
Product 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 for Recall
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 451
- Distribution
- Nationwide and internationally to Canada.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Synthes (USA) Products LLC. Units affected: 451.
Why was this product recalled? ▼
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2015. Severity: Moderate. Recall number: Z-2475-2015.
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