Recall Z-0650-2022— Merete Medical GmbH

Name: FDA recall Z-0650-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-18

Class II · Terminated

Class II FDA medical device recall by Merete Medical GmbH, initiated 2022-01-18, terminated 2023-02-16. It names one FDA 510(k) clearance: K151762. Product: Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only. Reason: Incorrect marketing label (25 mm) was applied to product size 20 mm..

Recalling firm: Merete Medical GmbH
Classification: Class II
Status: Terminated
Initiated: 2022-01-18
Terminated: 2023-02-16
Firm location: Berlin, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K151762 — PediatrOS RigidTack/FlexTackMerete Medical GmbH·cleared 2015-12-28

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

Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

Reason for recall

Incorrect marketing label (25 mm) was applied to product size 20 mm.

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