CLASS II Device recall · Reported 1 Jan 2014 · FDA Enforcement Report
ACL Reconstruction System is a pediatric recalled by OrthoPediatrics
OrthoPediatrics is recalling OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL, distributed nationwide in the US. The recall was initiated on 7 Nov 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0579-2014
- FDA event ID
- 67003
- Recalling firm
- OrthoPediatrics, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Nov 2013
- FDA classified
- 26 Dec 2013
- Reported
- 1 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 7 Nov 2013 | Recall initiated by company | |
| 26 Dec 2013 | Classified by FDA | +49 days |
| 1 Jan 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
Questions about this recall
Is ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction recalled?
Yes. OrthoPediatrics recalled ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction on 7 Nov 2013. The recall is Class II and its status is Terminated. Recall number Z-0579-2014.
Why was it 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.
Which lots are affected?
Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770
Where was it sold?
Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from OrthoPediatrics
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Orthex Large Bone Shoulder Bolt recalled by OrthoPediatrics | OrthoPediatrics | Device Malfunction | IN |
| Device | CLASS II | Orthex External Fixation Wire Sharp Bayonet mm recalled | OrthoPediatrics | Other | Nationwide |
| Device | CLASS II | Orthopedics Rod, Cocr, Single Hex Length-The Response" recalled | OrthoPediatrics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | ACL Reconstruction System ShieldLoc implant component recalled | OrthoPediatrics | Packaging Defects | Nationwide |
| Device | CLASS II | ACL Reconstruction System ShieldLoc implant component recalled | OrthoPediatrics | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |