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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84598

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

Open FDA event record

Event summary

Timeline bucket
December 19, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer 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

ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument

Z-0871-2020
Recall number
Z-0871-2020
Initiated
December 19, 2019
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
67 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach

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

Potential issue associated with the instrument -end of the shaft could fail to effectively mate with the broach

Code information

Lot Numbers: 827310, 711160, 203240

Distribution pattern

US Nationwide and Foreign: countries of Canada, CHINA, NETHERLANDS