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

Recall Z-1307-2022 — Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.

U.S. FDA — Device Enforcement · United States · 2022-06-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1307-2022
Date of alert
2022-06-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
K2M, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10888857326804
Reported risk: Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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