Merete Medical Recalls OsteoBridge Femoral Nails Due to Labeling Errors
Merete Medical GmbH is recalling 354 OsteoBridge Intramedullary Diaphysis Segment Fixation nails for the femur 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 a labeling error without reporting any illnesses or injuries, which aligns with the Moderate severity criteria for minor labeling errors.
Plain-English summary
Merete Medical GmbH is recalling 354 units of OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails intended for the femur. The recall was initiated because the product may be mislabeled.
The affected medical devices were distributed in the United States to California, Illinois, Maryland, Ohio, and New Jersey. The recall covers specific lots with use-by dates ranging from June 4, 2025, to July 24, 2025.
Healthcare providers and facilities that have received these products should stop using them and contact Merete Medical GmbH for instructions on how to return the devices.
The recalled product
- Product
- OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
- Manufacturer
- Merete Medical GmbH
- Hazard
- Affected units
- 354
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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