—#115596

Product

Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.

FDA product code: MRA — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P040048
Affected lot / code info: 62054788 61901417 61984072 61901423 61901426 61901427 61901428 61901435 61901437 61278096

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 #115596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.