Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control, 00-8790-003-00, Zimmer Inc., Warsaw, IN. Used to mate the inserter with the shell implant.
FDA Recall Z-0071-2011 · Posted 2010-10-15
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Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-03-19
Date Terminated2011-01-12
Product Quantity1125 all products
Reason for Recall
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution -- US, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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