Z-0191-2010

Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario...

Name: Z-0191-2010 Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario...
Creator: Biomet, Inc.
Published: 2009-09-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-09-09 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904842P. Intended to be implanted for... on 2009-09-09. The reason FDA records is "These anchors may be difficult to remove, or may not detach from the inserter shaft". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0191-2010
Status: Terminated
Initiated: 2009-09-09
Posted: 2009-11-12
Terminated: 2011-01-19
Recalling firm: Zimmer GmbH
Product: Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, Biomet sports Medicine, Inc., Ontario, CA; REF 904842P. Intended to be implanted for fixation of bone fractures and for bone reconstructions.
Product code: HWC Screw, Fixation, Bone
Reason for recall: These anchors may be difficult to remove, or may not detach from the inserter shaft.
Root cause tag: design
FDA root cause: Device Design
Action: Biomet issued an "Urgent Medical Device Recall Notice" dated September 9, 2009 informing consignees of the affected product and requesting return of the device. Distributors were instructed to notify their customers copy of the recall letter and to locate and return the products from user facilities. For further information, contact Biomet at 1-800-348-9500 or 1-574-372-3983.
Quantity in commerce: 894
Distribution: Worldwide Distribution -- United States and Belgium.
Product codes and lots: All lots. Lot Numbers: 006120, 006130, 006150, 310980, 457500, 457510, 457520, 528050, 549180, 597000, 597010, 689520, 689530, 689540, 843100, 843140, 933310 and 933320.

Product code HWC

K070389Class IIPeek Knotless AnchorsBiomet Sports Medicine, Inc. / cleared 2007-08-09

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)