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.
Check against the official notice below — it lists the full affected range.
OrthoPediatrics Corp has recalled ShieldLoc 6mm implant components from its ACL Reconstruction System due to incorrect labeling. Specifically, packages labeled as model 10-1008-4070 contain model 10-1008-4060 product, and packages labeled as 10-1008-4060 contain model 10-1008-4070 product. The recalled implants are used for fixation of tendons and ligaments during orthopedic procedures. Nine units with lot number 214320319A were distributed nationwide in the United States.
The recall affects implants with the UDI (01)00841132122198(17)240722(10)214320319A and lot number 214320319A. The source document does not specify what affected consumers or healthcare facilities should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: US Nationwide distribution. Quantity: 9 units Lot/code info: UDI: (01)00841132122198(17)240722(10)214320319A Lot# 214320319A
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.