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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78372

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

Open FDA event record

Event summary

Timeline bucket
February 14, 2014
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

ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide

Z-0102-2018
Recall number
Z-0102-2018
Initiated
February 14, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
21 (4 US and 17 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An undetected shift between the information displayed in the navigation software and the actual patient anatomy

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

An undetected shift between the information displayed in the navigation software and the actual patient anatomy

Code information

Serial #s; RO10009, RO10011, RO10014, and RO13023

Distribution pattern

OH, MI and TX