Recall Z-1122-2015— Biomet, Inc.

Name: FDA recall Z-1122-2015
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: K030055. Product: Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc). 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

K030055 — MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTSBiomet, Inc.·cleared 2003-08-11

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

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

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.