FDAFDA · Food and drugs·Recall number Z-2539-2020
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.
Published July 15, 2020 · Recall initiated: June 5, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- US Nationwide distribution.
- Lot
- UDI: (01)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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