OrthoPediatrics Recalls Child Nail Attachment Bolts Due to Binding Risk
OrthoPediatrics Corp is recalling 969 Child Nail Attachment Bolts because they may bind with the intramedullary nail, potentially delaying surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the hazard leads to 'delays in surgical procedures' rather than injury or death, fitting the criteria for a moderate severity issue without reported harm.
Plain-English summary
OrthoPediatrics Corp is recalling 969 units of Model No. 01-1501-0032 Child Nail Attachment Bolts. These bolts are components of the Pediatric Nailing Platform, an orthopedic implant system used for intramedullary fixation. The recall covers lots 173265-A, 175220-A, 177576-A, 183279-A, 187374-A, 192277-A, 192277-B, 192431-A, and 192431-B.
The recall was initiated because binding can occur between the attachment bolt and the intramedullary nail. This mechanical issue may lead to delays in surgical procedures. The FDA has classified this as a Class II recall.
The affected products were distributed worldwide, including nationwide in the United States and in Australia. Specific US states listed include AL, AZ, CA, CO, FL, GA, IA, IL, IN, KY, MD, MI, NC, NY, OH, OK, TN, TX, UT, VA, WA, and WI. Healthcare providers and facilities should stop using the affected bolts and contact OrthoPediatrics Corp for instructions on return or replacement.
The recalled product
- Product
- Model No. 01-1501-0032 (Child 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…
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 969
Distribution
Part of a larger recall action
This product is one of 2 recalled by OrthoPediatrics Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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