Z-0219-2020 Class II Terminated
FDA device recall Z-0219-2020 was initiated by OrthoPediatrics Corp on August 19, 2019 and is designated Class II. Reason for recall: Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures. The recall status is terminated (terminated April 30, 2020). Affected quantity: 969 total.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- August 19, 2019
- Termination Date
- April 30, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 969 total
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.
Distribution Pattern
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.
Code Information
175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C