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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63612

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 01, 2012
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

2 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 2

OSS Reamer Sleeve REF132-472661 KNEE REAMER SLEEVE 8.0 THRU 12.5 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.

Z-0471-2013
Recall number
Z-0471-2013
Initiated
November 01, 2012
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
46

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

Code information

Part Numbers 32-472661 , 8.0 thru 12.5 Lot 013020, 050310, 056280, 154670, 418380, 691220, 755510, 860171, 866460

Distribution pattern

Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.

device · product 2 of 2

OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable.

Z-0472-2013
Recall number
Z-0472-2013
Initiated
November 01, 2012
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
36

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.

Code information

Part Numbers 32-472662, 13.0 thru 20.0 Lot 154590, 156980, 519470, 519480, 542290, 628890, 755530

Distribution pattern

Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands.