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…

Recall date

November 22, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0882-2017

FDA classification

Class II

Brand / firm

Amendia, Inc

Sold / distributed

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

Why it was recalled

The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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