Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal surgery

U.S. FDA — Device Enforcement · United States · 2017-04-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1885-2017
Date of alert: 2017-04-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Amendia, Inc
Product category: device
Product type: Devices

Reported risk: Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were actually manufactured from nitinol.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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