OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm recall
OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of…
Why was OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: (01)00841132122211(17)240722(10)214320319A02 Lot#: 214320319A02
- Product
- OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of…
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 11 units
- Distribution
- US Nationwide distribution.
- Recall date
- July 15, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)