Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0219-2020 — 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

U.S. FDA — Device Enforcement · United States · 2019-08-19 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0219-2020
Date of alert: 2019-08-19
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: OrthoPediatrics Corp
Product category: device
Product type: Devices

Reported risk: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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