The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indica

FDA device recall Z-0416-2013 · posted 2012-11-21 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

Zimmer Trilogy Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.

Action taken

Zimmer sent a Urgent Medical Device Recall Notice dated September 20, 2012, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customer. Customers were instructed to locate quarantine and return affected product to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 for product in the USA. Customers were asked to complete the Inventory Return Certification Form and follow the instructions where to return this form. For further questions please call (574) 372-4807.

Root cause

Process control

Status

Terminated

Product code

LPH

Quantity affected

24 USA; 71 worldwide

Distribution

Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Swede

Date initiated

2012-09-20

Date posted

2012-11-21

Date terminated

2014-04-18

Location

Warsaw, IN