The Recall Desk
ModerateFDA (Devices)·Z-0437-2021·Announced 2020-11-18

Merete Medical Recalls Tibia Nails Due to Potential Mislabeling

Merete Medical GmbH is recalling 215 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the tibia 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 the source text identifies the issue as potential mislabeling without reporting any injuries, illnesses, or deaths, which aligns with the criteria for a Moderate severity score.

Plain-English summary

Merete Medical GmbH is recalling 215 units of OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails intended for the tibia. 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 lot numbers with use-by dates ranging from May 12, 2025, to July 22, 2025.

Healthcare providers and facilities should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or the FDA as directed.

The recalled product

Product
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia)
Affected units
215

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 →