Biomet, Inc. recalls Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for ort…

Recall date

January 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1082-2016

FDA classification

Class II

Brand / firm

Biomet, Inc.

Sold / distributed

Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia.

Why it was recalled

Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-sterilize the product. If oxidative material would flake off a component contained within the ePAK and enter the surgical field/wound an inflammatory reaction may occur. The inflammatory reaction may result in a foreign body reaction and/or metal hypersensitivity. Oxidized components have failed cytotoxicity testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation The Cross lock DVR ePAK Volar Rim Plates system is intended for fixation of fractures, mal unions, and osteotomies involving the distal radius. The DVR Wrist ePAK system is intended stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, radius, ulna, ankle, humerus, scapula and pelvis, particularly in osteopenic bone.