Z-1496-2014Class II

TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number...

Name: Z-1496-2014 TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number...
Creator: Zimmer, Inc.
Published: 2014-04-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-04-01 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component on 2014-04-01. FDA classified it as Class II and gives the reason as "The shell was missing the locking ring". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1496-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-01
Posted: 2014-04-24
Terminated: 2014-09-11
Recalling firm: Zimmer GmbH
Product: TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: The shell was missing the locking ring.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" notification dated April 2014 to their consignees. The notification included product description, product issue, health risks, and consignee responsibilities (including directions on how to return the affected product). The consignees were instructed to locate all products from lot 62490588 and quarantine them immediately; carry out a physical count of all affected product; complete and return the Inventory Return Certification Form via email to: [email protected]; return the recalled product, and notify Zimmer of any hospitals that you have further distributed the affected product and of surgeons that have implanted the product. Consignees with questions pertaining to the recall are directed to call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Quantity in commerce: 17 units
Distribution: Worldwide Distribution: US (nationwide) in states of: US: GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL; and countries of: Australia and Canada.
Product codes and lots: 00-6202-060-22; lot 62490588

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1496-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1496-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code LPH

K021891Class IIZimmer Trabecular Metal Modular Acetabular SystemZimmer, Inc. / cleared 2002-09-05

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)