Recall Z-1510-2020
Arthrex, Inc. · initiated October 1, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product Code: AR-8545-20; Batch Number: 10308261; UDI: 00888867124424
Reason for recall
Screws provided in the device package are 6 mm longer than intended.
FDA-determined cause: Employee error
Action taken
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 complaints@arthrex.com. Arthrex agencies were directed to contact Arthrex Field Logistics Services at FLS@arthrex.com 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 complaints@arthrex.com.
Details
- Recall number
- Z-1510-2020
- Initiated
- October 1, 2019
- Terminated
- September 8, 2021
- Product code
- HWC – Screw, Fixation, Bone
- Quantity
- 20 units
- Distribution
- US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
- Recalling firm
- Arthrex, Inc., Naples, FL