OrthoPediatrics Corp 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
OrthoPediatrics Corp
Lot Codes / Batch Numbers
175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C
Products Sold
175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C
OrthoPediatrics Corp is recalling Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platfor due to Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Recommended Action
Per FDA guidance
On August 19, 2019, the firm notified customers of the issue via emailed notice titled Urgent Medical Device Recall. Customers were informed of the issue of binding between the attachment bolt and the intramedullary nail. The firm asked customers to return all attachment bolts in the field. The issue does not impact intramedullary nails that have been implanted. No additional corrective actions need to be taken for product already implanted. Any questions regarding this recall can be directed to Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026