OrthoPediatrics ACL Reconstruction System is a pediatric… recallZ-0579-2014 · OrthoPediatrics Corp · initiated Nov 7, 2013
Class II Terminated All recalls posted in December 2013
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
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
FDA root cause category: Labeling design
What the company is doing
November 7, 2013 all consignees were notified of the Urgent Device recall via telephone calls and E-mail messages describing the product and reason for the recall,. The notice included directions to identify and quarantine the recalled devices returning product to OrthoPediatrics with completed return form to OrthoPediatrics via mail, email or courier service, or by photographing with a smart phone and emailing to [email protected] or by answering the recall specific questionsin an email to [email protected]
Recall details
- Recall number
- Z-0579-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 7, 2013
- Posted by the FDA
- Dec 26, 2013
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 40
- Product code
- MBI
- FDA submissions
- K130217
- Distribution
- Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
Product description
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.
Code information (models, lots, serial numbers)
Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, 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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