Home / Recalls / Zimmer Manufacturing B.V. / Z-1150-2016

Z-1150-2016 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
925

Product Description

Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee 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.

Distribution Pattern

US Nationwide Distribution

Code Information

lot no.: 61996176 61996176N 61996177 61996177N 61687334 61926537 62308501 61811187 61996179 61996179N

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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)
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