Arthrex recalls Low Profile Screw (4.5x20mm, AR-8545-20) due to being 6mm longer than intended. This may cause improper bone fixation during ankle fusion surgery. Affected units have batch number 10308261.
Screws provided in the device package are 6 mm longer than intended.
Arthrex is recalling a specific ankle surgery screw that's 6mm longer than it should be. This could lead to improper bone fixation during ankle fusion procedures. The recall affects surgeons and medical facilities using this product.
The screws are 6mm longer than intended, which could cause improper bone fixation during ankle fusion surgery. This might lead to complications like instability or delayed healing, but the risk is low as it's a surgical implant with a minor dimensional issue.
Surgeons and medical facilities that use the Arthrex Low Profile Screw (4.5 x 20 mm, AR-8545-20) for ankle fusion procedures are affected. The risk is low as this is a surgical implant with a minor dimensional issue.
Check for the product code AR-8545-20 on the packaging. Affected units have batch number 10308261 and UDI 00888867124424. This screw is used with ankle fusion plates.
Verify the product code AR-8545-20 and batch number 10308261 on the packaging.
The screws are 6mm longer than intended, which could cause improper bone fixation during ankle fusion procedures.
The recall record does not specify a remedy, so contact Arthrex directly for guidance.
This is a low-risk issue as it's a minor dimensional problem in a surgical implant that may affect bone fixation but not cause immediate injury.
We’ve drafted a message you can send Arthrex to request your refund or repair — edit it as you like.
Subject: Recall Z-1510-2020 — Arthrex Arthrex Hello, I own a Arthrex that is covered by recall Z-1510-2020 from Arthrex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
