Recall Z-1307-2022— K2M, Inc.

Name: FDA recall Z-1307-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-13

Class II · Ongoing

Class II FDA medical device recall by K2M, Inc., initiated 2022-06-13. It names one FDA 510(k) clearance: K171444. Product: Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.. Reason: 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..

Recalling firm: K2M, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-13
Firm location: Leesburg, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K171444 — YUKON OCT Spinal SystemK2m, Inc.·cleared 2017-08-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.