Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2538-2020·Announced 2020-07-15

OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors

OrthoPediatrics Corp is recalling 9 units of ShieldLoc 6mm implant components because some packages contain the wrong size.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a labeling error with no reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors or low-risk contamination.

Plain-English summary

OrthoPediatrics Corp is recalling 9 units of the ShieldLoc 6mm implant component, model number 10-1008-4060, from the ACL Reconstruction System. The recall is due to a labeling error where some packages labeled as model 10-1008-4070 contained model 10-1008-4060, and vice versa.

The affected product is intended for the fixation of tendons and ligaments during orthopedic reconstruction procedures, such as Anterior Cruciate Ligament (ACL) Reconstruction. The recall covers units distributed nationwide in the United States. The specific lot number is 214320319A, with a UDI of (01)00841132122198(17)240722(10)214320319A.

Healthcare providers and patients should check their inventory and records for this specific model and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No injuries or illnesses have been reported in connection with this recall.

The recalled product

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.
Manufacturer: OrthoPediatrics Corp
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
Affected units: 9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by OrthoPediatrics Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · OrthoPediatrics Corp

See all →

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Orthopedic Implant Bolts Recalled Due to Breakage Risk in Bone Correction
FDA (Devices) · 2023-02-22
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External Fixation Wire May Fracture During Surgery, Leaving Fragments in Patient
FDA (Devices) · 2022-09-14
Severe
OrthoPediatrics Recalls Spine Rods Due to Potential Fracture Risk
FDA (Devices) · 2020-08-05
Moderate
OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors
FDA (Devices) · 2020-07-15
Moderate
OrthoPediatrics Recalls Adolescent Nail Attachment Bolts Due to Binding Risk
FDA (Devices) · 2019-11-06

Same hazard · mis labeling