Home / Recalls / Zimmer Manufacturing B.V. / Z-1107-2016

Z-1107-2016 Class II Terminated

Recalled by Zimmer Manufacturing B.V. — Mercedita, PR

Recall Details

Product Type
Devices
Report Date
March 23, 2016
Initiation Date
January 11, 2016
Termination Date
April 13, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
0

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.

Distribution Pattern

US Nationwide Distribution

Code Information

lot no: 61889853

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  • Z-1677-2016 Class II — Zimmer Plates and Screws (ZPS) 4.0 mm Cancellous Screw Fully Threaded, 12 mm L (May 4, 2016)
  • Z-1673-2016 Class II — Zimmer Plates and Screws (ZPS) 3.5 mm Cortical Screw SelfTapping, 10 mm Length (May 4, 2016)
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