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Recall Observatory FDA recall evidence

Device 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.

Z-2539-2020

June 05, 2020

Class II

Product summary

Firm
OrthoPediatrics Corp
Event
Event 85837
Status
Terminated
Classification
Class II
Quantity
11 units
Official record key
device-enforcement:Z-2539-2020

Official wording

Reason: 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.

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

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.