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.
Reported: March 25, 2020 Initiated: October 1, 2019 #Z-1510-2020
Product Description
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.
Reason for Recall
Screws provided in the device package are 6 mm longer than intended.
Details
- Recalling Firm
- Arthrex, Inc.
- Units Affected
- 20 units
- Distribution
- US distribution to MA, MN, ND, OH, SD, TN. International distribution to Australia, Korea, China
- Location
- Naples, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Arthrex, Inc.. Units affected: 20 units.
Why was this product recalled? ▼
Screws provided in the device package are 6 mm longer than intended.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 25, 2020. Severity: Moderate. Recall number: Z-1510-2020.
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