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Synthes, Inc. recalls DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Recalled October 29, 2014 · FDA recall Z-0092-2015 · Synthes
Hazard
Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy. · FDA Class II
Units
11
Sold at
US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.
Description
Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.
Product
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Manufacturer(s)
Synthes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →