Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
FDA Recall Z-0386-2013 · Posted 2012-11-20
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Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeKWZ
Date Initiated2012-08-27
Date Terminated2013-08-27
Product Quantity1
Reason for Recall
Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
Firm Action
Zimmer contacted their customer beginning the week of August 27, 2012, via telephone. Zimmer informed the customer the reason of the recall.
The customer was instructed to quarantine and return the device to Zimmer Product Service, 1777 W. Center St. Warsaw, IN 46580. The customer was asked to provide information if the product was further distributed.
For further questions please call 574-372-4316.
Root Cause
Labeling Change Control
Distribution Pattern
USA (nationwide) including the states of Ohio, Carolinas and New England.
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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