Biomet 5.5 mm peek Allthread PEEK Knotless Anchor… recallZ-0191-2010 · Biomet, Inc. · initiated Sep 9, 2009
Terminated All recalls posted in November 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
These anchors may be difficult to remove, or may not detach from the inserter shaft.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0191-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 9, 2009
- Posted by the FDA
- Nov 12, 2009
- Recalling firm
- Biomet, Inc.
- Quantity
- 894
- Product code
- HWC
- FDA submissions
- K070389
- Distribution
- Worldwide Distribution -- United States and Belgium.
Product description
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.
Code information (models, lots, serial numbers)
All lots. Lot Numbers: 006120, 006130, 006150, 310980, 457500, 457510, 457520, 528050, 549180, 597000, 597010, 689520, 689530, 689540, 843100, 843140, 933310 and 933320.
Other devices under the same FDA submission
1 device cleared under K070389 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ALLTHREAD KNOTLESS PEEK-OPTIMA 904843PBiomet Orthopedics, LLC · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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