Lower riskMedical device recall · FDA · Published October 1, 2019
Arthrex Low Profile Screw Recall: 6mm Longer Than Intended
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.
“Arthrex Low Profile Screw Recall: 6mm Longer Than Intended.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66931-arthrex-low-profile-screw-recall-6mm-longer-than-intended. Based on FDA recall #Z-1510-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1510-2020%22&limit=1).
The FDA announced on 2019-10-01 that Arthrex, Inc. voluntarily recalled Low Profile Screws because the screws provided were 6 mm longer than intended. The agency issued recall number Z-1510-2020 for the Class II device.
How to tell if you have it
Brand: Arthrex
Product: Low Profile Screw, 4.5 x 20 mm
Model/Part Number: AR-8545-20
Batch Number: 10308261
UDI: 00888867124424
The hazard
The Low Profile Screw, 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. The hazard arises because the screws provided in the device package are 6 mm longer than intended.
Context
GovInfoNow's records show Arthrex, Inc. has had 12 other recalls on record since 2017-10-03. Other recent recalls of similar products include Arthrex Small Joint OATS Sets Recalled Due to Wrong Reamer Size Packaging (2022-11-02), Arthrex K-Wire 1.35mm x 170mm: Incorrect Size Risk (2022-03-25), and Arthrex Suture Anchor Recall: Not Sterilized Due to Packaging Seal (2021-06-14). Other recent recalls of similar products include Tornier Perip Screw Recall: Incorrect Labeling May Cause Surgery Delays (2025-12-19), Straumann Bone Level Tapered Implant May Be Wrong Length - Recall (2026-07-16), and XTANT Medical Xpress Pedicle Screw System: Incorrect Labeling Risk (2026-02-18).
How to tell if you have this one
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.
Brand
Arthrex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the product code AR-8545-20 and batch number 10308261 on the packaging.
Where it went and when
Where it was distributed
Distributed in 6 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Massachusetts, Minnesota, North Dakota, Ohio, South Dakota, Tennessee.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-1510-2020 (October 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1510-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.