Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD ...
FDA Recall #Z-1170-2016 — Class II — January 11, 2016
Product Description
Product 72 consists of all product code: JDI and same usage: Item no: 805002202 ZIMTRON HEAD 12/14 0X22 MM 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
226
Distribution
US Nationwide Distribution
Code Information
lot no.: 62065589
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated