Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orth

FDA device recall Z-1082-2016 · posted 2016-03-08 · Terminated

Recall details

Recalling firm

Biomet, Inc.

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.

Action taken

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 priority carrier for your shipment; if you have further distributed the product, you MUST notify hospital personnel of this action. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

Root cause

Package design/selection

Status

Terminated

Product code

LXT

Quantity affected

21,268

Distribution

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

Date initiated

2016-01-29

Date posted

2016-03-08

Date terminated

2017-09-05

Location

Warsaw, IN

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