FDA-Device2022-02-23Class II

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

Merete Medical GmbH
Hazard

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

Sold states
Domestic: Illinois; Foreign: Germany.
Affected count
26 units
Manufactured in
Alt-Lankwitz 102, N/A, Berlin, N/A, Germany
Products
Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0650-2022

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