Exact FDA event identifier

Event 70438

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: January 09, 2015
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: 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

2 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 2

Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

Z-1122-2015

Recall number: Z-1122-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Biomet, Inc.
Quantity: 17

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

Code information

Catalog Number: 13-104150 Lot Number Identification: 364600

Distribution pattern

Distributed in the states of VA and TX and the country of Japan.

device · product 2 of 2

Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.

Z-1123-2015

Recall number: Z-1123-2015
Initiated: January 09, 2015
Classification: Class II
Status: Terminated
Recalling firm: Biomet, Inc.
Quantity: 17

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

Code information

Catalog Number: 16-104152 Lot Number Identification: 427840

Distribution pattern

Distributed in the states of VA and TX and the country of Japan.