FDA-Device2014-10-29Class II
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Synthes, Inc.
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.
Sold states
US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.
Affected count
11
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0092-2015Don't want to check this manually?
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