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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95597

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 21, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357

Z-0477-2025
Recall number
Z-0477-2025
Initiated
October 21, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Biomet, Inc.
Quantity
691 (US); 2,045 (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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