Z-0125-2020 Class II Terminated
FDA device recall Z-0125-2020 was initiated by OrthoPediatrics Corp on August 19, 2019 and is designated Class II. Reason for recall: Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures The recall status is terminated (terminated October 26, 2020). Affected quantity: 211 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2019
- Initiation Date
- August 19, 2019
- Termination Date
- October 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211 units
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
Distribution Pattern
Nationwide Foreign: Australia
Code Information
Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836