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U.S. Department of Health and Human Services

Class 2 Device Recall Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control

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  Class 2 Device Recall Continuum Acetabular Systems Shell Inserter Adapter with Rotational Control see related information
Date Initiated by Firm March 19, 2010
Date Posted October 15, 2010
Recall Status1 Terminated 3 on January 12, 2011
Recall Number Z-0071-2011
Recall Event ID 55157
510(K)Number K091508  
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product 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.
Code Information 61301130, 61309997, 61326687, 61330544, 61389660, 61407677 and 61426853.
Recalling Firm/
Manufacturer		 Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact Dale Miller
574-267-6131
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 1125 all products
Distribution Worldwide Distribution -- US, Singapore, Australia, Portugal, Germany, Switzerland, Spain, Finland, United Kingdom, Israel, Italy and Sweden.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LXH and Original Applicant = ZIMMER, INC.
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