Reported Apr 16, 2014 · Terminated
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in…
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 · N/A
Is this the product you have?
- Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft)
- Part numberM040-SS-110
- Used in Implant Catalogue numberFD-040(LS)-SS. orthopedic intramedullary rod
- Lot codes and dates
- Lot #: 130424-15 (only
- laser marked on the Part Number
M040-SS-110)Lot #: 121109-11 &130424-15 [Indicated
- on the label of the Catalogue NumberFD-040(L)-SS]
- Amount recalled
- Total of 5 units (2 units in the US and 3 units in Germany)
Where it was sold
Why it was recalled
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
This product could cause temporary or reversible health problems — stop using it.
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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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