Z-0611-2010

Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile...

Name: Z-0611-2010 Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile...
Creator: Biomet, Inc.
Published: 2009-12-11
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-12-11 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile, Biomet Sports Medicine, Warsaw, IN; REF 905456... on 2009-12-11. The reason FDA records is "The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0611-2010
Status: Terminated
Initiated: 2009-12-11
Posted: 2010-01-13
Terminated: 2010-10-18
Recalling firm: Zimmer GmbH
Product: Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile, Biomet Sports Medicine, Warsaw, IN; REF 905456. Intended for use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee.
Product code: HWC Screw, Fixation, Bone
Reason for recall: The anchor label states it contains a flexible shaft, but this lot actually contians a rigid shaft.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Biomet Sports Medicine notified the single consignee by letter dated December 11, 2009. The firm requested that users locate and return the affected product and return a business reply card. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983.
Quantity in commerce: 6
Distribution: Nationwide Distribution -- Alabama.
Product codes and lots: Lot 695710.

Product code HWC

K040475Class IIMicromax Suture AnchorBiomet, Inc. / cleared 2004-05-21

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)