Merete PediatrOS RigidTack surgical device recalled for incorrect size label
Merete Medical recalled 26 units of Merete PediatrOS RigidTack (pediatric orthopedic implant, 20 mm) due to incorrect marketing label stating 25 mm. Distribution: Illinois and Germany.
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: This is a minor labeling error on a surgical device with no reported illnesses or injuries. While a size mismatch could pose theoretical risk during use, the absence of adverse events and Class II FDA classification support a Moderate severity rating.
Plain-English summary
Merete Medical GmbH has recalled the Merete PediatrOS RigidTack, Reference CP20120, Size 20 mm, a sterile prescription-only pediatric orthopedic surgical device. A total of 26 units are affected by this recall.
The product was distributed with an incorrect marketing label indicating a size of 25 mm when the actual product size is 20 mm. This labeling discrepancy between the external label and the actual product could cause confusion during clinical use.
The affected units were distributed domestically to Illinois and internationally to Germany. The lot number is MS2117816, with UDI (01)04048266150394(17)260706(10)MS2117816.
The recalled product
- Product
- Merete PediatrOS RigidTack, REF CP20120, Size 20 mm, Sterile, Rx Only
- Manufacturer
- Merete Medical GmbH
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. CP20120
- Lot No. MS2117816
- UDI No. (01)04048266150394(17)260706(10)MS2117816
Distribution
Distributed in 1 state:
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