Device product
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.
Z-0579-2014
Product summary
- Event
- Event 67003
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40
- Official record key
device-enforcement:Z-0579-2014
Official wording
Reason: Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
Code information: Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770
Distribution pattern: Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
Derived failure modes
-
Unknown
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.