Z-1510-2020Class II

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...

Name: Z-1510-2020 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...
Creator: Arthrex, Inc.
Published: 2019-10-01
License: https://open.fda.gov/license/

Arthrex GmbH / initiated 2019-10-01 / Terminated / root cause: manufacturing process

FDA source

Arthrex, Inc. began a recall of 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... on 2019-10-01. FDA classified it as Class II and gives the reason as "Screws provided in the device package are 6 mm longer than intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1510-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-01
Posted: 2020-03-17
Terminated: 2021-09-08
Recalling firm: Arthrex GmbH
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.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Screws provided in the device package are 6 mm longer than intended.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Arthrex notified customers of the recall on about 10/01/2019, via "URGENT: REMOVAL NOTIFICATION" letter. Customers were informed that the Low Profile Screw, labeled as 4.5 x 20 mm, in their package measures 6 mm longer than intended. Customers were instructed to immediately discontinue use, sale, and distribution of affected screws and to acknowledge receipt of the recall notification. Direct customers were directed to contact Anthrex Product Surveillance at 866-267-9138 or [email protected]. Arthrex agencies were directed to contact Arthrex Field Logistics Services at [email protected] as soon as possible to arrange for return of affected products. An email also accompanied the recall letter and requested that customers return all affected product. Questions can be addressed to Arthrex Product Surveillance at 866-267-9138 or [email protected].
Quantity in commerce: 20 units
Distribution: US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
Product codes and lots: Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1510-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1510-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-17

Product code HWC

K141735Class IIArthrex Ankle Fusion Plating SystemArthrex, Inc. / cleared 2014-08-15

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)