Reported Jan 1, 2014 · Terminated
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing…
OrthoPediatrics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.
- Lot codes and dates
Part 01-1008-0040/0047 Lot 132762F132763F132764F132765F132766F132768F132769F132770
- Amount recalled
- 40
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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