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.
Reported: January 1, 2014 Initiated: November 7, 2013 #Z-0579-2014
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.
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.
Details
- Recalling Firm
- OrthoPediatrics Corp
- Units Affected
- 40
- Distribution
- Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by OrthoPediatrics Corp. Units affected: 40.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2014. Severity: Moderate. Recall number: Z-0579-2014.
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