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PolyLock Midfoot

FUSION ORTHOPEDICS, LLC · Model CD-CA-1050 · UDI-DI 00840124521872

HXQ Prescription
1
510(k) clearances
13
Adverse events
1
Recalls
52
Facilities

Description

Calcaneus Schanz Pin 5mm

Recalls

DateFirmReason
2014-09-26Biomet, Inc.An investigation identified that high level friction may exist between the needle and Mamba suture passer instrument, causing the needle to break during use.

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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.