REF 905571, 5.5 mm Lactoscrew Anchors,WITH Needles #2 Maxbraid (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biome

FDA device recall Z-1233-2012 · posted 2012-03-21 · Terminated

Recall details

Recalling firm

Biomet, Inc.

Reason for recall

Biomet initiated this action following an internal audit which discovered the component level package insert was included in the product packaging in place of the end level product package insert (01-501072). This meant that the Indications, Contraindications, Possible Adverse Effects, and some Warnings are not present with the packaged device.

Action taken

Biomed Inc. sent an Urgent Medical Device Recall Notice dated January 25, 2012 to distributors, hospitals, and OR managers via US mail. The notice identified the product, description of problem, possible adverse health consequences, and actions to be taken, including directions to immediately locate devices and stop device use ,with directions for return. A copy of the correct package insert was included with directions to report any procedures performed outside of indications for use. Receipt confirmation was requested by calling 800-348-9500, extension 3983 or 3009. The notice included a list of units invoiced to the account with a FaxBack Response form to be filled out and sent to the Attention of Angie Dickson, Biomet, 56 East Bell Drive Warsaw, In 46580. Questions concerning the recall should be directed to 574-371-3983 or 574-371-3009, M-F 8-5PM(EST)

Root cause

Packaging

Status

Terminated

Product code

HWC

Quantity affected

944

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.

Date initiated

2012-01-25

Date posted

2012-03-21

Date terminated

2013-04-12

Location

Warsaw, IN

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