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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77116

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

Open FDA event record

Event summary

Timeline bucket
April 13, 2017
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

Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

Z-2056-2017
Recall number
Z-2056-2017
Initiated
April 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
4238

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
loss of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.

Code information

Model numbers: 402282 and 402282J - Cobalt HV Bone Cement 402438 - Cobalt MV Bone Cement 402283J - Cobalt HV Bone Cement With Gentamicin 402438 Lot: 507830 402282J Lot: 668140 402282 Lot: 508220 402283J Lot: 189780

Distribution pattern

TX. Japan Mexico

Field note

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