Reported Sep 2, 2015 · Terminated
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of…
Synthes (USA) Products LLC
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) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- 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
- Lot codes and dates
- Part Number03.501.080
- Lot numbers
3783492378391337884963822332751672876068817635218765317876591687666085767193476798257689244769437777006917705157772059977385727738573774049877427137767497779764878037687806881781867778186827821672782708878318557833606785840780680788130898813097581457938159386816641781869548207769820919082159698215999824195882909598290968
- Amount recalled
- 451
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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