Device 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
Z-0125-2020
Product summary
- Event
- Event 83767
- Status
- Terminated
- Classification
- Class II
- Quantity
- 211 units
- Official record key
device-enforcement:Z-0125-2020
Official wording
Reason: Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Code information: Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836
Distribution pattern: Nationwide Foreign: Australia
Derived failure modes
-
Unknown
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures