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OsteoSinter® EVANS wedge 22W x 22L x 8H mm

AMES MEDICAL PROSTHETIC SOLUTIONS S.A. · Model P00206B1 · UDI-DI 08437019951528

PLF Prescription
1
510(k) clearances
23
Adverse events
9
Recalls
38
Facilities

Recalls

DateFirmReason
2026-07-10Paragon 28, Inc.Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
2026-07-10Paragon 28, Inc.Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
2018-09-28Paragon 28, Inc.It has been determined that the wedge implant kit is permanently mislabeled with the wrong size. The wedge implant is a 10mm size and is permanently marked as a 12mm size. Use of t
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.
2016-04-22Arthrex, Inc.Potential for polystyrene particulate presence.

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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.