Arthrex Recalls Low Profile Screws Due to Incorrect Length
Arthrex, Inc. is recalling 20 units of Low Profile Screws because they are 6 mm longer than intended. The defect may affect bone fixation.
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. The hazard involves a dimensional defect in a medical device that could affect intended function, but no injuries or illnesses are reported in the source text.
Plain-English summary
Arthrex, Inc. is recalling 20 units of the Low Profile Screw, 4.5 x 20 mm (Product Code: AR-8545-20). The recall is due to a manufacturing defect where the screws provided in the device package are 6 mm longer than intended. These screws are used with the Ankle Fusion Line of plates to provide internal unicortical or bicortical bone fixation.
The affected units were distributed in the United States to Massachusetts, Minnesota, North Dakota, Ohio, South Dakota, and Tennessee. International distribution occurred in Australia, Korea, and China. The specific batch number is 10308261 and the UDI is 00888867124424.
Healthcare providers and patients should check their inventory and records for this specific product code and batch number. If the product is found, it should be removed from use and returned to Arthrex, Inc. for credit or replacement.
The recalled product
- Product
- Low Profile Screw, 4.5 x 20 mm The Low Profile ScrewTM, 4.5 x 20 mm, AR-8545-20, is used with the Ankle Fusion Line of plates and is intended to provide internal unicortical or bicortical bone fixation.
- Manufacturer
- Arthrex, Inc.
- Affected units
- 20
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: AR-8545-20
- Batch Number: 10308261
- UDI: 00888867124424
Distribution
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