The Recall Desk
ModerateFDA (Devices)·Z-0435-2021·Announced 2020-11-18

Merete Medical Recalls OsteoBridge Knee Arthrodesis Nails for Mislabeled Product

Merete Medical GmbH is recalling 306 units of OsteoBridge Intremedullary Knee Arthrodesis nails because the product may be mislabeled.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Merete Medical GmbH is recalling 306 units of OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails. The recall was initiated because the product may be mislabeled.

The affected medical devices were distributed in the United States to the states of California, Illinois, Maryland, Ohio, and New Jersey. The recall covers specific lots with use-by dates ranging from January 8, 2025, to July 21, 2025.

Healthcare providers and patients should stop using the affected devices and contact Merete Medical GmbH for further instructions on the recall.

The recalled product

Product
OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails
Affected units
306

Distribution

Distributed in 5 states:

Part of a larger recall action

This product is one of 4 recalled by Merete Medical GmbH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →