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.
Reported: November 6, 2019 Initiated: August 19, 2019 #Z-0219-2020
Product Description
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 for Recall
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Details
- Recalling Firm
- OrthoPediatrics Corp
- Units Affected
- 969 total
- Distribution
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by OrthoPediatrics Corp. Units affected: 969 total.
Why was this product recalled? ▼
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2019. Severity: Moderate. Recall number: Z-0219-2020.
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