The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassemb

FDA device recall Z-3279-2011 · posted 2011-09-27 · Terminated

Recall details

Recalling firm

Zimmer Inc.

Reason for recall

Lot # 61132698 and Lot 001122467 (added 9/ 18/2012) may have a manufacturing non conformance that could prevent the devices from functioning as intended. Specifically, devices in the affected lot may have a locking ring groove depth that prevents the corresponding liner from snapping into the shell. The groove provides the locking ring room to displace when inserting a liner into the shell. Th

Action taken

Zimmer, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated July 27, 2011 to all affected customers of lot 61132698 and 9/18/2012 to only affected customer of lot 001122467. The letters describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to stop using and to quarantine the affected product. An Inventory Return Certification Form was included with the letter for customers to complete and return to Zimmer, Inc. via fax at (574) 372-4265. Replacement product will be provided for all returned product. Contact Zimmer, Inc. at 1-800-613-6131 for questions regarding this recall.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JDI

Quantity affected

24 devices lot 61132689; 1 device lot 001122467

Distribution

Worldwide Distribution-USA (nationwide) including the states of CA, NC,NY, PA, WA, and WI and countries of Australia, Germany, The Netherlands, and Switzerland.

Date initiated

2011-09-01

Date posted

2011-09-27

Date terminated

2013-08-29

Location

Warsaw, IN

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