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TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with… recallZ-1496-2014 · Zimmer, Inc. · initiated Apr 1, 2014

Class II Terminated All recalls posted in April 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The shell was missing the locking ring.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-1496-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 1, 2014
Posted by the FDA
Apr 24, 2014
Recalling firm
Zimmer, Inc.
Quantity
17 units
Product code
LPH
FDA submissions
K021891
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 description

TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.

Code information (models, lots, serial numbers)

00-6202-060-22; lot 62490588

Other devices under the same FDA submission

10 devices cleared under K021891 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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