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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

JuggerLoc/ToggleLoc 2.9mm Drill Guides Recalled for Warped Packaging

Agency Publication Date: November 15, 2024
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Summary

Biomet, Inc. is recalling approximately 2,736 JuggerLoc/ToggleLoc 2.9mm Drill Guides (Model 110027357) because the product packaging may be warped. This defect can make the guides difficult to remove from their packaging during use or cause them to be physically warped when used in surgery. While no specific injuries have been reported, this issue could extend surgical procedures while staff look for replacement parts or lead to local tissue reactions if surgical complications occur.

Risk

Warped packaging can damage the drill guides or make them difficult to extract during a medical procedure. If a surgeon attempts to use a warped guide or must stop a procedure to find a replacement, it can result in an extended time under anesthesia or lead to an adverse local tissue reaction requiring additional surgical intervention.

What You Should Do

  1. This recall affects JuggerLoc/ToggleLoc 2.9mm Drill Guides sold under Model number 110027357 with UDI-DI 00880304857254.
  2. Check your surgical inventory for the following lot numbers printed on the packaging: 0002446326, 0002446333, 0002452241, 0002453378, or 0002467342. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this safety alert.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: JuggerLoc/ToggleLoc 2.9mm Drill Guide
Model / REF:
110027357
Lot Numbers (51):
0002446326
0002446333
0002452241
0002453378
0002467342
0002476076
0002476077
0002476078
0002481506
0002481724
0002486540
0002486541
0002490256
0002493107
0002496066
0002497715
0002497716
0002500871
0002500872
0002504026
0002504027
0002504031
0002504032
0002504033
0002504034
0002504035
0002504036
0002504037
0002504546
0002513868
0002517982
0002517983
0002527929
0002527931
0002528042
0002528043
0002528044
0002528045
0002544040
0002592614
0002592615
0002592616
0002592617
0002592618
0002602484
0002602487
0002602490
0002614121
0002614122
0002614123
UDI:
00880304857254

Recall quantity includes 691 units in the US and 2,045 units internationally.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95597
Status: Active
Manufacturer: Biomet, Inc.
Sold By: Hospital suppliers; Surgical equipment distributors
Manufactured In: United States
Units Affected: 691 (US); 2,045 (OUS)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.