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.
Check against the official notice below — it lists the full affected range.
OrthoPediatrics Corp has recalled certain ShieldLoc implant components from its ACL Reconstruction System due to incorrect labeling. Specifically, packages labeled as model 10-1008-4070 contained the 10-1008-4060 product, while packages labeled as 10-1008-4060 contained the 10-1008-4070 product. This labeling mix-up affects 11 units that were distributed nationwide. The affected lot is 214320319A02 (UDI: 00841132122211, dated 240722, reference number 214320319A02).
The ShieldLoc implant component is intended for fixation of tendons and ligaments during orthopedic procedures. The recall record does not specify a remedy or instructions for affected consumers.
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: 11 units Lot/code info: UDI: (01)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.