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.
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 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
- Manufacturer
- Merete Medical GmbH
- Hazard
- Affected units
- 306
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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