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Zimmer Manufacturing B.V. recalls Product 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW
Recalled March 23, 2016 · FDA recall Z-1136-2016 · 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
4752
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 38 consists of all product under product code: HSB and same usage: Item no: 225303255 INTERLOCKING IM SCREW LG 225303555 INTERLOCKING IM SCREW LG 225303755 INTERLOCKING IM SCREW LG 225307055 INTERLOCKING IM SCREW LG 225302742 INTERLOCKING IM SCREW MED 225303242 INTERLOCKING IM SCREW MED 225307042 INTERLOCKING IM SCREW MED 225302737 INTERLOCKING IM SCREW SML 225303237 INTERLOCKING IM SCREW SML 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 →