Recall Z-1510-2020 ยท HWC Screw, Fixation, Bone
Arthrex, Inc.
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.
| Date | Oct 1, 2019 |
| Status | Terminated |
| Reason | Screws provided in the device package are 6 mm longer than intended. |
| 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 complaints@arthrex.com. Arthrex agencies were directed to contact Arthrex Field Logistics Services at FLS@arthrex.c |
| Quantity | 20 units |
| Distribution | US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141735 | ARTHREX ANKLE FUSION PLATING SYSTEM Arthrex, Inc., Aug 15, 2014 |