Exact FDA event identifier

Event 79397

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

Open FDA event record

Event summary

Timeline bucket: January 03, 2018
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

Trabecular Metal¿ Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)

Z-0939-2018

Recall number: Z-0939-2018
Initiated: January 03, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zimmer Biomet, Inc.
Quantity: 24

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Two lots of hip implants are mislabeled.

Code information

Part Numbers: 1. 00-7864-013-00, Lot: 63703649; 2. 00-7864-013-20, Lot: 63703681

Distribution pattern

Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.