FDA-Device2016-07-06Class II
K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
Integra LifeSciences Corp.
Hazard
The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.
Sold states
Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
Affected count
182 units
Manufactured in
311 Enterprise Dr, Plainsboro, NJ, United States
Products
K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2084-2016Don't want to check this manually?
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