Pega Medical Inc — Class II medical device recall Z-1448-2014
Terminated recall by Pega Medical Inc., reported 2014-04-16, distributed nationwide. The Male Components in this lot are made of material with lower strength than manufacturing specifications.
| Recall number | Z-1448-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pega Medical Inc., Laval, N/A, Canada |
| Recall initiated | 2014-02-07 |
| Classified | 2014-04-10 |
| Reported by FDA | 2014-04-16 |
| Terminated | 2014-04-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE |
| Reason classes | potency |
| Lot numbers | 121109-11, 130424-15 |
| Model numbers | FD-040, M040-SS-110 |
Product
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.
Reason for recall
The Male Components in this lot are made of material with lower strength than manufacturing specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1448-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.