Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 ...
FDA Recall #Z-1167-2016 — Class II — January 11, 2016
Product Description
Product 69 consists of all product under product code: JDI and same usage: Item no: 785301701 VERSYS CEMENTED FEM STEM 785301521 VERSYS CEMENTED FEM STEM 15X140MM X-OFF 785301601 VERSYS CEMENTED FEM STEM 16X145MM For use in total or hemi 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
13
Distribution
US Nationwide Distribution
Code Information
lot no.: 370967 00370967N 62279438 62012576 62012576N
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated