OrthoPediatrics Recalls ShieldLoc ACL Implant Components Due to Labeling Errors
OrthoPediatrics Corp is recalling 11 units of ShieldLoc 7mm implant components because some packages contain the wrong size product.
What this means for you
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: This is a Class II recall involving a labeling error where the wrong size implant is packaged. While the risk of using the wrong size is significant, the source text does not report any injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
OrthoPediatrics Corp is recalling 11 units of the ShieldLoc 7mm implant component, model number 10-1008-4070, from the ACL Reconstruction System. The recall is due to a labeling error where some packages labeled as model 10-1008-4070 were found to contain 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 214320319A02, and the UDI is (01)00841132122211(17)240722(10)214320319A02.
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 the appropriate regulatory authority as directed.
The recalled product
- 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.
- Manufacturer
- OrthoPediatrics Corp
- Hazard
- Affected units
- 11
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)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02
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 →Related recalls
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