Reported May 6, 2015 · Terminated
Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For…
Pega Medical 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: Pega Medical Inc. · 1111 Autoroute Chomedy · Laval · N/A
Is this the product you have?
- Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval IM Telescopic System. For orthopedic procedures. This instrument is included in the Fassier-Duval IM Telescopic System instrument tray. This instrument is marked with the catalogue number and lot number.
- Lot codes and dates
- Lot 290609-01
- Amount recalled
- 9 units (5 units in the US and 4 units international)
Where it was sold
Why it was recalled
The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may result in a reduction of the total strength of the instrument, possibly leading to deformation, wear, and tip breakage.
This product could cause temporary or reversible health problems — stop using it.
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