Biomet, Inc.: REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ,(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 number

Z-1232-2012

Recalling firm

Biomet, Inc.

Product

REF 905570 3.5 mm Lactoscrew Anchor Size 2 white Maxbraid ,(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.

Status

Terminated

Initiated

2012-01-25

Posted

2012-03-21

Terminated

2013-04-12

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.

Root cause

Packaging

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)

Quantity

1414

Distribution

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

Lot, serial or model codes

40370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 377930, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 83271040370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 37793040370, 40380, 193300, 193390, 193420, 262880, 262890, 262900, 295530, 295540, 314440, 377910, 377930, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 832710, 430410, 430420, 430430, 430440, 435400, 435410, 435420, 463950, 463960, 464240, 499820, 610320, 610330, 610340, 727730, 727740, 727760, 727770, 727800, 727810, 727830, 832710.

510(k) numbers

["K080088"]

PMA numbers

not on file

Product code

HWC

Firm FEI

1825034

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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