Recall Z-0579-2014
OrthoPediatrics Corp · initiated November 7, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770
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.
FDA-determined cause: Labeling design
Action taken
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 logistics@orthopediatrics.com or by answering the recall specific questionsin an email to mfox@orthopediatrics.com
Details
- Recall number
- Z-0579-2014
- Initiated
- November 7, 2013
- Posted by FDA
- December 26, 2013
- Terminated
- May 9, 2014
- Product code
- MBI – Fastener, Fixation, Nondegradable, Soft Tissue
- Quantity
- 40
- Distribution
- Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
- Recalling firm
- OrthoPediatrics Corp, Warsaw, IN