Medical device manufacturer recalls mislabeled interference screws nationwide
SCIENCE & BIO MATERIALS has recalled ComposiTCP 30 Interference screws due to mislabeling. The recall affects 72 units distributed nationwide in the US.
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 an FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is mislabeling, which constitutes a minor labeling error, and the recall was voluntary and firm-initiated.
Plain-English summary
SCIENCE & BIO MATERIALS is recalling the ComposiTCP 30 Interference screw D 7- L:25 mm (REF 110004605) due to mislabeling. This is a voluntary recall initiated by the manufacturer.
The affected product (Lot #190491, with use-before date 01/01/2022) was distributed nationwide in the United States, with 72 units affected. The recall was initiated on October 7, 2021.
Consumers and healthcare providers who have this product should contact the manufacturer or their supplier for instructions regarding the mislabeled units. The product should not be used until the labeling discrepancy is resolved.
The recalled product
- Product
- ComposiTCP 30 Interference screw D 7- L:25 mm, REF 110004605
- Manufacturer
- SCIENCE & BIO MATERIALS
- Hazard
- Affected units
- 72
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)
- Product code: 110004605
- Lot #: 190491
- Use before 01/01/2022. GTIN 03760154006767
Distribution
Distributed nationwide across the United States.
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