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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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)
- Manufacturer
- Merete Medical GmbH
- Hazard
- Affected units
- 215
Distribution
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 →Related recalls
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