Recall Z-0125-2020— OrthoPediatrics Corp
Class II · Terminated
Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2019-08-19, terminated 2020-10-26. It names one FDA 510(k) clearance: K172583. 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. Reason: Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures.
- Recalling firm
- OrthoPediatrics Corp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-08-19
- Terminated
- 2020-10-26
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Data sourced from openFDA. This site is unofficial and independent of the FDA.