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

Recall Z-0881-2017 — K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18, Part Number 9080-18U; 1.4mm x 24 Threaded Guide Wire, Part Number 9080-24T; K-Wire Non-Threaded 24, Part Number 9080-24U; Blunt K-Wire, 18 inches, Threaded, Part

U.S. FDA — Device Enforcement · United States · 2016-11-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0881-2017
Date of alert: 2016-11-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Amendia, Inc
Product category: device
Product type: Devices

Reported risk: The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.

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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