FDA Recall Terminated

REF 905572, 5.5mm Lactoscrew Anchor,WI Maxbraid No Nd (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN Product Usage: The Biomet Sports Medicine Soft Tissue Anchoring Devices are resorbable repair devices used to attach soft tissue to bone.

Recall: Z-1234-2012 · Initiated January 25, 2012

Recall

Recall Number: Z-1234-2012
Event Number: 61104
Firm: Biomet, Inc.
FEI Number: 1825034
Product Code: HWC
Status: Terminated
Root Cause: Packaging
Initiated: January 25, 2012
Posted: March 21, 2012
Terminated: April 12, 2013
Address: 56 E Bell Dr, Warsaw, IN, 46582-6989

Description

Reason

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

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)

Distribution

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

Quantity

837