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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68931

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

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Event summary

Timeline bucket
July 01, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA

Z-2242-2014
Recall number
Z-2242-2014
Initiated
July 01, 2014
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
461

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.

Code information

Catalog Number: 32-48847 4 Lot Numbers: 022120, 022180, 162530, 232460, 475500 and 475510. 699240, 793350, 793570 Additional Scope: 065030, 095780, 164290, 235870, 253670, 273630, 308620, 418970, 420030, 421210, 570460, 585260, 619690, 708240, 711430, 726490, 816160, 896810, 929690, 953540, 968950

Distribution pattern

California, IA, FL, MD, UT, SC, AL, IL, CO, MA, KS, GA, WA, NV, AR, NH, OK,Pennsylvania, New York, Texas, Virginia, New Jersey, North Carolina, Kentucky, Michigan, Ohio, Wisconsin, Louisiana, Arizona, Indiana, South Dakota, Missouri & Montana. In addition to Korea, B.V., Japan, Puerto Rico, UK, Chile, New Zealand, Australia, & Canada