OrthoPediatrics Adolescent attachment bolt used with the Pediatric… — Class II medical device recall Z-0125-2020
Terminated recall by OrthoPediatrics Corp, reported 2019-10-23, distributed nationwide. Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgic
| Recall number | Z-0125-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2019-08-19 |
| Classified | 2019-10-12 |
| Reported by FDA | 2019-10-23 |
| Terminated | 2020-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 211 units |
| UPC / GTIN / UDI-DI | 00841132149836 |
| Serial numbers | 174784-A, 175221-A, 177577-A, 183280-A, 187375-A, 189808-A, 192279-B, 192432-B |
| Model numbers | 01-1503-0032 |
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 for recall
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0125-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.