U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The rods are packaged in packages with unacceptable seals. in some cases, the integrity of the seal is compromised by channels or voids.
조치
Amendia sent an Urgent Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter requested that customers examine their inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. Customers with questions were instructed to call the following numbers:
770-575-5224
770-575-5236
770-575-5369
For questions regarding this recall call 404-610-7215.
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
제품 설명
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