OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sl
FDA device recall Z-0579-2014 · posted 2013-12-26 · Terminated
Recall details
- Recalling firm
- OrthoPediatrics Corp
- 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.
- 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
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MBI
- Quantity affected
- 40
- Distribution
- Nationwide Distribution including the states of CA, KY, OH, RI, and TN.
- Date initiated
- 2013-11-07
- Date posted
- 2013-12-26
- Date terminated
- 2014-05-09
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOPEDIATRICS ACL RECONSTRUCTIVE SYSTEM (K130217) | OrthoPediatrics Corp. | 2013-06-20 |