Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77626

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

Open FDA event record

Event summary

Timeline bucket
November 06, 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, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.

Z-0160-2018
Recall number
Z-0160-2018
Initiated
November 06, 2014
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
31 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).

Code information

Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.

Distribution pattern

US distribution in AR, GA, OH, MI, and TX.