Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1122-2015

January 09, 2015

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 70438
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-1122-2015

Official wording

Reason: 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.

Derived failure modes

  • 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.