FDA Device recall Z-1885-2017
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…
- FDA Device
- Class II
- terminated
- Published 2017-05-03
On 2017-05-03 the FDA classified a Class II recall of 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… by Amendia, citing mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1885-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-06 |
| Published | 2017-05-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Amendia |
| Distribution | GA, KS, TX |
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.
Identifiers
| code_info | Lot Number 135561 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1885-2017%22
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