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Arcos® One-piece Revision System

Biomet Orthopedics, LLC · Model 11-304120 · UDI-DI 00880304683228

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1
510(k) clearances
673
Adverse events
2
Recalls
119
Facilities

Recalls

DateFirmReason
2023-06-16Conformis, Inc.30mm screws were labeled as 25mm screws.
2013-01-24Stelkast CoFirm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell.

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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.