Recall Z-0219-2020 ยท HSB Rod, Fixation, Intramedullary And Accessories
OrthoPediatrics Corp
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
| Date | Aug 19, 2019 |
| Status | Terminated |
| Reason | Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. |
| Root cause | Nonconforming Material/Component |
| Action | On August 19, 2019, the firm notified customers of the issue via emailed notice titled Urgent Medical Device Recall. Customers were informed of the issue of binding between the attachment bolt and the intramedullary nail. The firm asked customers to return all attachment bolts in the field. The issue does not impact intramedullary nails that have been implanted. No additional corrective actions need to be taken for product already implanted. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orth |
| Quantity | 969 total |
| Distribution | Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172583 | OrthoPediatrics PediNail Intramedullary Platform Orthopediatrics, Inc., May 10, 2018 |