Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 ...
FDA Recall #Z-1160-2016 — Class II — January 11, 2016
Product Description
Product 62 consists of all product under product code: LPH and same usage: Item no: 620003620 TRILOGY ACET SHELL 36MM OD MULTI For use in total hip arthroplasty
Reason for Recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Recalling Firm
Zimmer Manufacturing B.V. — Mercedita, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
400
Distribution
US Nationwide Distribution
Code Information
lot no.: 62313588
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated