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.
What this means for you
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
Related recalls
Same manufacturer · Arthrex, Inc.
See all →- HighArthrex Small Joint OATS Sets recalled for incorrect reamer size packaging
FDA (Devices) · 2022-12-14
- HighK-Wire Devices Recalled for Incorrect Length and Diameter Specifications
FDA (Devices) · 2022-05-11
- HighSuture Anchor Products Recalled Due to Improper Sterilization
FDA (Devices) · 2021-07-28
- ModerateArthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error
FDA (Devices) · 2021-04-21
- LowArthrex Recalls Cannulated Drill Bits Due to Incorrect Color Indicator
FDA (Devices) · 2021-04-07
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighUnited Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12