FDA-Device2016-12-28Class II
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Amendia, Inc
Hazard
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Sold states
Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico
Affected count
1078 units
Manufactured in
1755 W Oak Pkwy, N/A, Marietta, GA, United States
Products
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0882-2017Don't want to check this manually?
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