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Continuum Acetabular Systems Shell Inserter Adapter without… recallZ-0072-2011 · Zimmer Inc. · initiated Mar 19, 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 firm has received reports of users encountering difficulties in usage leading to surgical delays or minor damage to a threaded surface of the shell implant.

FDA root cause category: Device Design

What the company is doing

The firm sent Urgent: Device Removal letters dated 3/15/2010. The letter identified the affected product, described the issue, discussed the clinical implications, and provided a list of required actions. The consignees were instructed to perform an inventory of the recalled product and report the amount on hand to Zimmer by completing the Inventory Return Certification Form. After Zimmer received the report, they would send out new product to the consignee. After new product was received the consignees were instructed to return the recalled product to Zimmer. The firm expects to have all product replaced by 4/30/2010. If there are any questions or additional info needed, consignees should contact Zimmer, Inc. at 1-800-613-6131 or 574-372-4463.

Recall details

Recall number
Z-0072-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 19, 2010
Posted by the FDA
Oct 15, 2010
Recalling firm
Zimmer Inc.
Quantity
1125 all products
Product code
LXH
FDA submissions
K091508
Distribution
Worldwide Distribution -- US, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden.

Product description

Continuum Acetabular Systems Shell Inserter Adapter without Rotational Control, 00-8790-003-10, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.

Code information (models, lots, serial numbers)

61255960, 61286739, 61293344, 61297228, 61301146, 61303916, 61321619, 61341496, 61341497, 61351886, 61361912, 61361919, 61369266, 61371666, 61371667, 61387139, 61396637 and 61413131.

Other devices under the same FDA submission

40 devices cleared under K091508 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 55157).

Sources and updates

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