Recall Z-0125-2020
OrthoPediatrics Corp · initiated August 19, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836
Reason for recall
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0125-2020
- Initiated
- August 19, 2019
- Terminated
- October 26, 2020
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Quantity
- 211 units
- Distribution
- Nationwide Foreign: Australia
- Recalling firm
- OrthoPediatrics Corp, Warsaw, IN