Recall Z-1082-2016 ยท LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Biomet, Inc.
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 p
| Date | Mar 8, 2016 (initiated Jan 29, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Package design/selection |
| Action | The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated 1/29/2016 to the affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. The customers were instructed to immediately locate and remove the identified device(s); carefully follow instructions on enclosed Response Form; complete and return Response Form within three (3) business days via email to CPWARFieldAction@zimmerbiomet.com prior to return of product, use prio |
| Quantity | 21,268 |
| Distribution | Worldwide distribution: US (Nationwide) and countries of: Panama; Korea; Japan; Netherlands; Ecuador; Chile; Canada; and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112345 | DISTAL VOLAR RADIUS PLATING SYSTEMS Medos International SARL, Oct 31, 2011 |
| K132704 | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW Biomet, Oct 9, 2013 |
| K133939 | MODIFIED DISTAL RADIUS PLATING SYSTEM Biomet, Apr 1, 2014 |
| K140622 | DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE Biomet, Inc., May 13, 2014 |