OrthoPediatrics Recalls Adolescent Nail Attachment Bolts Due to Binding Risk
OrthoPediatrics Corp is recalling 969 Adolescent Nail Attachment Bolts because binding between the bolt and nail may delay surgical procedures.
What this means for you
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, and the hazard involves potential delays in surgical procedures rather than direct physical injury or death, fitting the criteria for a moderate severity issue.
Plain-English summary
OrthoPediatrics Corp is recalling 969 units of Model No. 01-1503-0032 Adolescent Nail Attachment Bolts. These bolts are components of the Pediatric Nailing Platform, an orthopedic implant system used for intramedullary fixation. The recall covers lots 175221-A, 177577-A, 183280-A, 187375-A, 189808-A, 192279-B, 192432-B, and 198082-C.
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 agency classifies 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 should contact OrthoPediatrics Corp for instructions on returning the affected components.
The recalled product
- 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 in
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 969
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 175221-A 177577-A 183280-A 187375-A 189808-A 192279-B 192432-B 198082-C
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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