CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report
Low Profile Screw, mm The Low Profile ScrewTM, mm recalled by Arthrex
Arthrex is recalling Low Profile Screw, mm The Low Profile ScrewTM, mm, AR-8545-20, is used with the Ankle, distributed nationwide in the US. The recall was initiated on 1 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1510-2020
- FDA event ID
- 84030
- Recalling firm
- Arthrex, Naples, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Oct 2019
- FDA classified
- 17 Mar 2020
- Reported
- 25 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 1 Oct 2019 | Recall initiated by company | |
| 17 Mar 2020 | Classified by FDA | +168 days |
| 25 Mar 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Screws provided in the device package are 6 mm longer than intended.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
Nationwide MassachusettsMinnesotaNorth DakotaOhioSouth DakotaTennessee
Questions about this recall
Is Low Profile Screw, mm The Low Profile ScrewTM, mm, AR-8545-20, is used with the Ankle recalled?
Yes. Arthrex recalled Low Profile Screw, mm The Low Profile ScrewTM, mm, AR-8545-20, is used with the Ankle on 1 Oct 2019. The recall is Class II and its status is Terminated. Recall number Z-1510-2020.
Why was it recalled?
Screws provided in the device package are 6 mm longer than intended.
Which lots are affected?
Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424
Where was it sold?
US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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