OrthoPediatrics ACL Reconstruction System is a recall
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set…
Why was OrthoPediatrics ACL Reconstruction System is a recalled?
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
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?
Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770
- Product
- OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set…
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 40
- Distribution
- Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
- Recall date
- January 1, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)