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The Trabecular Metal Modular Acetabular System is a modular… recallZ-3279-2011 · Zimmer Inc. · initiated Sep 1, 2011

Terminated All recalls posted in September 2011

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

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-3279-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 1, 2011
Posted by the FDA
Sep 27, 2011
Recalling firm
Zimmer Inc.
Quantity
24 devices lot 61132689; 1 device lot 001122467
Product code
JDI
FDA submissions
K021891
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.

Product description

The Trabecular Metal Modular Acetabular System is a modular acetabular cup system consisting of a shell with a preassembled locking ring, a liner, and optional screws. The Shells are available in a variety of sizes and are designed to be used with Trilogy Acetabular System liners. The shell implants are used to replace the hip socket during total hip arthroplasty. The device is indicated for primary or revision surgery for rehabilitating hips damaged as a result on noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis,protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis and diastrophic variant. The device is intended for either cemented or noncemented use.

Code information (models, lots, serial numbers)

Part 00-6202-052-21, Lot 61132698 and lot 001122467

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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