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.
FDA Recall Z-0191-2010 · Posted 2009-11-12
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2009-09-09
Date Terminated2011-01-19
Product Quantity894
Reason for Recall
These anchors may be difficult to remove, or may not detach from the inserter shaft.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- United States and Belgium.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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