Recall Z-1085-2024— Stryker, Inc.

Name: FDA recall Z-1085-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-06

Class II · Ongoing

Class II FDA medical device recall by Stryker, Inc., initiated 2023-12-06. It names one FDA 510(k) clearance: K211594. Product: Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm. Reason: The microcatheter IFU contains an intended use that has not been evaluated by the FDA..

Recalling firm: Stryker, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-06
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K211594 — Trevo Trak 21 MicrocatheterStryker Neurovascular·cleared 2021-11-26

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

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

Reason for recall

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

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