FDA Device recall Z-0579-2014
OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation T…
- FDA Device
- Class II
- terminated
- Published 2014-01-01
On 2014-01-01 the FDA classified a Class II recall of OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation T… by Orthopediatrics, citing part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0579-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-07 |
| Published | 2014-01-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Orthopediatrics |
| Distribution | US |
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.
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.
Identifiers
| code_info | Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0579-2014%22
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