Reported Nov 6, 2019 · Terminated
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage:…
OrthoPediatrics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform
- Product Usagean 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
- Lot codes and dates
175221-A177577-A183280-A187375-A189808-A192279-B192432-B198082-C
- Amount recalled
- 969 total
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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