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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78299

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

Open FDA event record

Event summary

Timeline bucket
April 25, 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

Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.

Z-0070-2018
Recall number
Z-0070-2018
Initiated
April 25, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.

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

A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.

Code information

Part Number: CP116574 Lot Number: 073840

Distribution pattern

This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.