FDAFDA · Food and drugs·Recall number 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 system.
Published November 6, 2019 · Recall initiated: August 19, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- OrthoPediatrics Corp
- Distributor
- Worldwide distributions - US Nationwide distributions including states of AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Country of Australia.
- Lot
- 175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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