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U.S. Department of Health and Human Services

Class 2 Device Recall Dual Stylet Needle

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  Class 2 Device Recall Dual Stylet Needle see related information
Date Initiated by Firm November 22, 2016
Create Date December 22, 2016
Recall Status1 Completed
Recall Number Z-0882-2017
Recall Event ID 75858
Product Classification Orthopedic manual surgical instrument - Product Code LXH
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
Code Information Part Number 812-11R-15 Lot Number 121945, 123231, 124146, 125418, 126822, 127868, 128459, 128464, 130818, 131492, 13496, 132594, 132813, 134514, 134515, 134517, 134909, 135290, 137302
Recalling Firm/
Manufacturer		 Amendia, Inc
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information Contact Bryan Brosseau
404-610-7215
Manufacturer Reason
for Recall		 The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
FDA Determined
Cause 2		 Employee error
Action 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.
Quantity in Commerce 1078 units
Distribution 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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