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Amendia, Inc recalls Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Ne
Recalled December 28, 2016 · FDA recall Z-0882-2017 · Amendia
Hazard
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids. · FDA Class II
Units
1078 units
Sold at
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
Description
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Product
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
Manufacturer(s)
Amendia, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →