FDA Enforcement
Class II
Terminated
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
Recall: Z-2733-2020
·
Reported August 5, 2020
Enforcement
- Recall Number
- Z-2733-2020
- Event ID
- 86021
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arthrex, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 5, 2020
- Initiation Date
- June 24, 2020
- Classification Date
- July 29, 2020
- Termination Date
- February 16, 2021
- Address
- 1370 Creekside Blvd, N/A, Naples, FL, 34108-1945, United States
Description
Sterile Low Profile Screw, Titanium, 6.7 x 65mm Part Number: AR-8967-2865S - Product Usage: is intended to be used as a stand-alone bone screw, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions.
Reason
Screws provided in packaging are 5mm shorter than intended
Code Info
Batch Number: 10706233 UDI Number:00888867056411
Distribution
International distribution in the countries of Denmark, United Kingdom, Sweden, Japan, Netherlands
Quantity
28 units