Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SC...
FDA Recall #Z-1107-2016 — Class II — January 11, 2016
Product Description
Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL Product Usage: Temporary internal fixation devices designed to stabilize fractures during the normal healing process.
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
Distribution
US Nationwide Distribution
Code Information
lot no: 61889853
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated