Recall Z-1123-2015— Biomet, Inc.

Name: FDA recall Z-1123-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-09

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-01-09, terminated 2015-10-22. It names one FDA 510(k) clearance: K093235. Product: Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.. 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-09
Terminated: 2015-10-22
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K093235 — RINGLOC + HYBRID ACETABULAR SYSTEMBiomet, Inc.·cleared 2010-04-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.