Recall Z-1885-2017— Amendia, Inc
Class II · Terminated
Class II FDA medical device recall by Amendia, Inc, initiated 2017-04-06, terminated 2017-05-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 01.4mm 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. Reason: Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol..
- Recalling firm
- Amendia, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-06
- Terminated
- 2017-05-30
- Firm location
- Marietta, GA, United States
Product description
01.4mm 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
Reason for recall
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Data sourced from openFDA. This site is unofficial and independent of the FDA.