ACL Sleeve Installation Tool Sizes: 6mm, 6.5mm, 7.0mm… recallZ-2560-2014 · OrthoPediatrics Corp · initiated Jul 25, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from OrthoPediatrics Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Weld fractures on the Sleeve Installation Tool for ACL reconstruction system.
FDA root cause category: Nonconforming Material/Component
What the company is doing
OrthoPediatrics sent a Notification letter dated July 25, 2014 to all affected customers. The letter Identified the affected product, problem and actions to be taken. The letter informed customers to take immediate possession of all affected product within their control and at any of their health care facilities and immediately return the recalled device(s) to OrthoPediatrics Corp. This notice and the attached Reply Form should be forwarded if the affected product was further distributed. .
Recall details
- Recall number
- Z-2560-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 25, 2014
- Posted by the FDA
- Aug 29, 2014
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 56 units
- Product code
- MBI
- FDA submissions
- K130217
- Distribution
- US Nationwide Distribution.
Product description
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.
Code information (models, lots, serial numbers)
Part #: Lot Code: 01-1008-0040 132762 01-1008-0041 F132764, F132763 01-1008-0042 F132763, F132764 01-1008-0043 F132765, F132766 01-1008-0044 F132766, F132765 01-1008-0045 F132768 01-1008-0046 F132769 01-1008-0047 F132770
Other devices under the same FDA submission
2 devices cleared under K130217 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- OrthoPediatrics ACL Reconstruction System 10-1008-4060Orthopediatrics Corp. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall0 reports
- OrthoPediatrics ACL Reconstruction System 10-1008-4070Orthopediatrics Corp. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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