Reported Nov 26, 2014 · Terminated
10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable…
Synthes, 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, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- 10 mm/135 degree Titanium Cannulated Trochanteric
- Fixation Nail 170 MM - Sterileintended to treat stable and unstable fractures of the proximal femur
- Lot codes and dates
- part number456.316S
- lot number7782247
- Amount recalled
- 6
Where it was sold
Why it was recalled
The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction and construct stability which may lead to non-union/malunion.
This product could cause temporary or reversible health problems — stop using it.
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