Amendia Recalls Mac Pin Non-Cannulated Screws Due to Incorrect Length Labeling
Amendia, Inc. is recalling 41 Mac Pin Non-Cannulated Screws because the packaging incorrectly lists the length as 460 mm, while the actual length is 60 mm.
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 hazard is a minor labeling error (incorrect length) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Amendia, Inc. is recalling 41 units of the Mac Pin Non-Cannulated Screw, 6.5 x 60mm (Model #85-6560-1, Lot #132117). The recall is due to incorrect labeling on the product lot.
The source text indicates that although the pins are laser-etched with a length of 460 mm, the actual physical length of the pins is 60 mm. This discrepancy in labeling could lead to incorrect usage or identification of the medical device.
The affected products were distributed to Georgia, USA. Consumers and healthcare providers who possess these specific screws should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Mac Pin Non-Cannulated Screw, 6.5 x 60mm
- Manufacturer
- Amendia, Inc
- Hazard
- Affected units
- 41
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 (2)
- Model #85-6560-1
- Lot #132117
Distribution
Distributed in 1 state:
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