Reported Apr 17, 2013 · Terminated
Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking)…
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?
- Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.
- Lot codes and dates
- Part number 355.28, all lot numbers
- Amount recalled
- 328
Where it was sold
Why it was recalled
Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.
This product could cause temporary or reversible health problems — stop using it.
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