Z-2538-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2020
- Initiation Date
- June 5, 2020
- Termination Date
- May 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 units
Product Description
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Reason for Recall
ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product labeled as 10-1008-4060 was found to have 10-1008-4070 product in the package.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: (01)00841132122198(17)240722(10)214320319A Lot# 214320319A