—#112648

Product

Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.

FDA product code: KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K071718
Affected lot / code info: Item 00-6334-062-36, Lot 62023769

Why it was recalled

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: USA (nationwide) including the states of Ohio, Carolinas and New England.

Timeline

Recall initiated: 2012-08-27
Posted by FDA: 2012-11-20
Terminated: 2013-08-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112648. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.