Recall Z-1082-2016— Biomet, Inc.

Name: FDA recall Z-1082-2016
Creator: U.S. Food and Drug Administration
Published: 2016-01-29

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2016-01-29, terminated 2017-09-05. It names 4 FDA 510(k) clearances: K140622, K133939, K132704 and 1 more. Product: 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.. Reason: 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-01-29
Terminated: 2017-09-05
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

4 on FDA's record

K140622 — DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATEBiomet, Inc.·cleared 2014-05-13
K133939 — MODIFIED DISTAL RADIUS PLATING SYSTEMBiomet·cleared 2014-04-01
K132704 — DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiomet·cleared 2013-10-09
K112345 — DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARL·cleared 2011-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.