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Zimmer Manufacturing B.V. recalls Product 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW
Recalled March 23, 2016 · FDA recall Z-1134-2016 · 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
268
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 36 consists of all product under product code: HSB and same usage: Item no: 225302745 INTERLOCKING IM SCREW 4.5 225303045 INTERLOCKING IM SCREW 4.5 225303245 INTERLOCKING IM SCREW 4.5 225303545 INTERLOCKING IM SCREW 4.5 225303745 INTERLOCKING IM SCREW 4.5 225304045 INTERLOCKING IM SCREW 4.5 225304245 INTERLOCKING IM SCREW 4.5 225304545 INTERLOCKING IM SCREW 4.5 225305045 INTERLOCKING IM SCREW 4.5 225305245 INTERLOCKING IM SCREW 4.5 225305545 INTERLOCKING IM SCREW 4.5 225305745 INTERLOCKING IM SCREW 4.5 225306045 INTERLOCKING IM SCREW 4.5 225306545 INTERLOCKING IM SCREW 4.5 225307045 INTERLOCKING IM SCREW 4.5 Product Usage: An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
Manufacturer(s)
Zimmer Manufacturing B.V.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →