Z-1235-2012

REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports...

Name: Z-1235-2012 REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports...
Creator: Biomet, Inc.
Published: 2012-01-25
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-01-25 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (Lactosorb L-15 resorbable copolymer ) Sterile, EO; Biomet Sports Medicine, Warsaw, IN Product Usage: The Biomet... on 2012-01-25. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1235-2012
Status: Terminated
Initiated: 2012-01-25
Posted: 2012-03-21
Terminated: 2013-04-12
Recalling firm: Zimmer GmbH
Product: REF 905580, 6. 8 mm Lactoscrew 2#2 MBNo. (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.
Product code: HWC Screw, Fixation, Bone
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.
Root cause tag: packaging
FDA 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 in commerce: 11
Distribution: Worldwide Distribution - USA (nationwide) and the countries of: Argentina, Brazil, Chile, Colombia, Israel, Mexico and Netherlands.
Product codes and lots: 622920

Product code HWC

K080088Class IIBiomet Sports Medicine Anchor Devices and Ziploop ConstructsBiomet Manufacturing, Inc. / cleared 2008-06-11

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)