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Zimmer Manufacturing B.V. recalls Product 9 consists of all product under HRS, and same usage: Item no: 47494502601 4.5 BROAD SCP PLT, 26 HOL
Recalled March 23, 2016 · FDA recall Z-1107-2016 · Zimmer Manufacturing B.V
Hazard
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. · FDA Class II
Units
0
Sold at
US Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Zimmer Manufacturing B.V.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →