Model No. 01-1503-0032 recall
Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system…
Why was Model No. 01-1503-0032 recalled?
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C
- Product
- Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system…
- Recalling firm
- OrthoPediatrics Corp
- Quantity
- 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.
- Recall date
- November 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)