Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
FDA Recall Z-0094-2015 · Posted 2014-10-20
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Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2014-10-01
Date Terminated2015-03-02
Product Quantity19
Reason for Recall
The affected products are missing polar boss threads.
Firm Action
Zimmer sent an "URGENT MEDICAL DEVICE RECALL- LOT SPECIFIC" notifications dated October 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Your Responsibilities
1. Review the notification and ensure affected personnel are aware of the contents.
2. If you find any product from the affected lot , quarantine the product and notify your Zimmer sales representative.
3. Your Zimmer sales representative will remove the recalled product from your facility.
4. For patients that previously had this product implanted, it is recommended that you continue your normal post operative follow up routine.
5. If after reviewing this notification you have further questions or concerns please call the customer call center at
1-800-348-2759 between 8:00 am and 5:00pm EST.
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.
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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