Recalls for Bone Wedge

9 on file

Paragon 28, Inc.
Open, ClassifiedAug 14, 2026
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Paragon 28, Inc.
Open, ClassifiedAug 14, 2026
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Paragon 28, Inc.
TerminatedDec 10, 2019
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 the product could result in improper preparation of the surgical site causing delays in surgery.
Arthrex, Inc.
TerminatedUnknown
Potential for polystyrene particulate presence.
Arthrex, Inc.
TerminatedUnknown
Potential for polystyrene particulate presence.
Arthrex, Inc.
TerminatedUnknown
Potential for polystyrene particulate presence.
Arthrex, Inc.
TerminatedUnknown
Potential for polystyrene particulate presence.
Arthrex, Inc.
TerminatedUnknown
Potential for polystyrene particulate presence.
Arthrex, Inc.
TerminatedUnknown
Potential for polystyrene particulate presence.