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OsteoMed

OSTEOMED LLC · Model 3551 · UDI-DI 00845694014472

LZJ Prescription
10
510(k) clearances
79
Adverse events
1
Recalls
9
Facilities

Description

Metatarsal Broach--Small Left

Recalls

DateFirmReason
2014-06-09Arthrosurface, Inc.An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.