OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
Reported: July 15, 2020 Initiated: June 5, 2020 #Z-2539-2020
Product Description
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - 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.
Details
- Recalling Firm
- OrthoPediatrics Corp
- Units Affected
- 11 units
- Distribution
- US Nationwide distribution.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.. Recalled by OrthoPediatrics Corp. Units affected: 11 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 15, 2020. Severity: Moderate. Recall number: Z-2539-2020.
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