Recall record at a glance
| Official record | Z-1448-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Pega Medical Inc. |
| Report date | Apr 16, 2014 |
| Recall initiation date | Feb 7, 2014 |
| Quantity | Total of 5 units (2 units in the US and 3 units in Germany) |
| Location | Laval, N/A, Canada |
Official product description
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
Why the product was recalled
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Distribution information
Worldwide Distribution - USA Nationwide in the states of Missouri, Texas, and the country of Germany.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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