Z-1754-2015Class III

Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma...

Name: Z-1754-2015 Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma...
Creator: Biomet, Inc.
Published: 2015-04-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-04-16 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165... on 2015-04-16. FDA classified it as Class III and gives the reason as "Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1754-2015
Classification: Class III
Status: Terminated
Initiated: 2015-04-16
Posted: 2015-06-11
Terminated: 2016-05-16
Recalling firm: Zimmer GmbH
Product: Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma Uncemented, & Mallory/Head Total Hip System Size 12, 165 mm, Bi- Metric Femoral Components. Hip joint replacement components include: femoral stems, femoral heads, acetabular shells, and acetabular liners.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Biomet sent an Urgent Medical Device Recall Notice letter dated April 29, 2015 to affected customers via Fed-Ex. The letter identifed the affected product, problem and actions to be taken. Customers were asked to complete the attached response form and return it along with recalled product to Biomet. For questions callt (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in commerce: 1315
Distribution: Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.
Product codes and lots: Part Numbers: 11-104212 & 11-104211;Use-by 2025-03-18; Lot Numbers: 127340, 182030, 349650.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1754-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1754-2015	Class III	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10
Z-1755-2015	Class III	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10
Z-1756-2015	Class III	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10
Z-1757-2015	Class III	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-10

Product code LPH

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)