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Zimmer Trabecular metal Modular Acetabular system 56 mm… recallZ-0060-2011 · Zimmer Inc. · initiated Aug 18, 2010

Terminated All recalls posted in October 2010

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 threads on the device were not completely machined and therefore would not mate with athe corresponding cup positioner/shell inserter.

FDA root cause category: Other

What the company is doing

The firm, Zimmer, made telephone calls using a phone script document entitled "Urgent: Medical Device Recall" Phone Script Call Communication, to the customers that received this product starting on 8/18/2010. The telephone calls were to determine the status of the recalled product. A Zimmer Field Action Strategy notification dated August 9, 2010 was also provided. The notifications/phone script described the product, problem and actions to be taken by the customers. The customers were instructed to remove the 00-6202-056-22, lot 61091653 product from their inventory and return to Zimmer Product Service Department, Attn: Product Service, 1777 West Center Street, Warsaw, IN 45680. Note: If the product had been used, no action was necessary. The returned product will be evaluated to determine how many of the devices had the defect. If you have any questions, please call (574) 371-8852.

Recall details

Recall number
Z-0060-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 18, 2010
Posted by the FDA
Oct 14, 2010
Recalling firm
Zimmer Inc.
Quantity
24
Product code
LPH
FDA submissions
K021891
Distribution
Worldwide distribution:USA including states of: MI, IN, WI, MO, CA, VA, MD, TX, NC, PA, OR, WA, FL, GA, NY, ME, AZ, and UT and country including Canada.

Product description

Zimmer Trabecular metal Modular Acetabular system 56 mm Porous shell with cluster holes, Catalog 00-6202-056-22, Zimmer Inc., Warsaw, IN. This device is indicated for primary or revision surgery for rehabilitating hips damaged as the result of noninflammatory degenerative joint disease, including osteoarthritis, fused hip, avascular necrosis, traumatic arthritis and fracture of the pelvis.

Code information (models, lots, serial numbers)

61091653

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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