01 — Class II medical device recall Z-1885-2017
Terminated recall by Amendia, Inc, reported 2017-05-03, distributed in GA, KS, TX. Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manu
| Recall number | Z-1885-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amendia, Inc, Marietta, GA, United States |
| Recall initiated | 2017-04-06 |
| Classified | 2017-04-27 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2017-05-30 |
| Distributed | GA, KS, TX |
| Quantity | 15 units |
| Reason classes | labeling |
| Lot numbers | 135561 |
| Model numbers | 9080B-18T |
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 for recall
Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1885-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.