Recall Z-0125-2020 ยท HSB Rod, Fixation, Intramedullary And Accessories
OrthoPediatrics Corp
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
| Date | Aug 19, 2019 |
| Status | Terminated |
| Reason | Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures |
| Root cause | Device Design |
| Action | OrthoPediatrics, Inc. notified Distributors by letter via email on 8/19/19 , stating reason for recall, health risk and action to take: Distributors have been instructed to review their inventory and the inventory at their clinical sites to recover the product. Questions contact: Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897. |
| Quantity | 211 units |
| Distribution | Nationwide Foreign: Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172583 | OrthoPediatrics PediNail Intramedullary Platform Orthopediatrics, Inc., May 10, 2018 |