ACL Sleeve Installation Tool Sizes: 6mm — Class II medical device recall Z-2560-2014
Terminated recall by OrthoPediatrics Corp, reported 2014-09-10, distributed nationwide. Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
| Recall number | Z-2560-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2014-07-25 |
| Classified | 2014-08-29 |
| Reported by FDA | 2014-09-10 |
| Terminated | 2015-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 56 units |
| Reason classes | device malfunction |
| Lot numbers | 01-1008-0040, 01-1008-0041, 01-1008-0042, 01-1008-0043, 01-1008-0044, 01-1008-0045, 01-1008-0046, 01-1008-0047, 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770 |
| Model numbers | 01-1008-0040, 01-1008-0041, 01-1008-0042, 01-1008-0043, 01-1008-0044, 01-1008-0045, 01-1008-0046, 01-1008-0047, 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770ACL |
Product
ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 10.0mm Product Usage: The OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system that offers both the fixation devices and instrument in one system. The insertion tool is used with a mallet to tap the tunnel sleeve implant into a counter-bored hole in the bone.
Reason for recall
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2560-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.