Model No — Class II medical device recall Z-0218-2020
Terminated recall by OrthoPediatrics Corp, reported 2019-11-06, distributed nationwide. Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical pr
| Recall number | Z-0218-2020 |
|---|---|
| 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 | 2019-10-25 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 969 total |
| Model numbers | 01-1501-0032 |
Product
Model No. 01-1501-0032 (Child Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the system.
Reason for recall
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays 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-0218-2020. 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.