CLASS II ONGOING Device recall · Reported 27 Nov 2024 · FDA Enforcement Report

JuggerLoc/ToggleLoc Drill Guide recalled by Biomet

Biomet is recalling JuggerLoc/ToggleLoc Drill Guide, distributed nationwide in the US. The recall was initiated on 21 Oct 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI 00880304857254 Lots 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 0002624306

Quantity recalled691 (US); 2,045 (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0477-2025
FDA event ID: 95597
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Ongoing
Recall initiated: 21 Oct 2024
FDA classified: 15 Nov 2024
Reported: 27 Nov 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

21 Oct 2024	Recall initiated by company
15 Nov 2024	Classified by FDA	+25 days
27 Nov 2024	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI-DI 00880304857254 Lots 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 0002624306

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Singapore, Switzerland.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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