Z-1122-2015Class II

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

Name: Z-1122-2015 Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Creator: Biomet, Inc.
Published: 2015-01-09
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-01-09 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc) on 2015-01-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1122-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-09
Posted: 2015-02-17
Terminated: 2015-10-22
Recalling firm: Zimmer GmbH
Product: Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Biomet notified all domestic and foreign customers via FEDEx overnight on 1/9/2015. Response forms were provided, customers were instructed to notify hospital personnel if product was further distributed, and remove recalled products from circulation. Replacement parts were made available, customers may contact Audrey Daenzer, Field Action Specialist, Regulatory Compliance Biomet, Inc., [email protected], or 574-372-1570 Monday- Friday 8 AM to 5 PM.
Quantity in commerce: 17
Distribution: Distributed in the states of VA and TX and the country of Japan.
Product codes and lots: Catalog Number: 13-104150 Lot Number Identification: 364600

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1122-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1122-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-17
Z-1123-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-17

Product code LPH

K030055Class IIMallory/head Total Hip System; Ha Mallory/head Total Hip System; Bi-Metric Femoral ComponentsBiomet, Inc. / cleared 2003-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)