FDA Device recall Z-0219-2020
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt)
- FDA Device
- Class II
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class II recall of Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt) by Orthopediatrics, citing binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0219-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-19 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Orthopediatrics |
| Distribution | US |
Product
Model No. 01-1503-0032 (Adolescent 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
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Identifiers
| code_info | 175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0219-2020%22
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