OrthoPediatrics Corp: 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.

Agency Publication Date: July 10, 2020

Affected Products

Product: 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.

UDI: (01)00841132122198(17)240722(10)214320319A Lot# 214320319A

Lot Numbers:

214320319A

Product: 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.

UDI: (01)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02

Lot Numbers:

214320319A02

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85837

Status: Resolved

Manufacturer: OrthoPediatrics Corp

Manufactured In: United States

Units Affected: 2 products (9 units; 11 units)

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Sources: FDA iRES · Raw API Response

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Affected Products

UDI: (01)00841132122198(17)240722(10)214320319A Lot# 214320319A

Lot Numbers:

214320319A

UDI: (01)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02

Lot Numbers:

214320319A02