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U.S. Department of Health and Human Services

Class 2 Device Recall Guide Wires

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 Class 2 Device Recall Guide Wiressee related information
Date Initiated by FirmApril 06, 2017
Date PostedApril 25, 2017
Recall Status1 Terminated 3 on May 30, 2017
Recall NumberZ-1885-2017
Recall Event ID 77069
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery
Code Information Lot Number 135561
FEI Number 3007970248
Recalling Firm/
Manufacturer		 Amendia, Inc
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information ContactBryan Brosseau
404-610-7215
Manufacturer Reason
for Recall		Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
FDA Determined
Cause 2		Process design
ActionAmendia sent an Urgent Medical Device Recall Letter dated April 6, 2017, and April 25, 2017, to all affected customers. The letter requested that they check inventory, quarantine product for return to Amendia, and requested a sub-recall. The letter also included a reply form to be returned to Amendia. Customers with questions were instructed to call Amendia Customer Service at 770-575-5224. For questions regarding this recall call 404-610-7215.
Quantity in Commerce15 units
DistributionUS distribution to GA, KS & TX
Total Product Life CycleTPLC 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.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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