—#114393

Product

Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K934765
Affected lot / code info: 61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745

Why it was recalled

Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.

Root cause (FDA determination)

Process control

Action the firm took

Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.

Timeline

Recall initiated: 2012-09-14
Posted by FDA: 2013-02-04
Terminated: 2014-06-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114393. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.