OrthoPediatrics Recalls Adolescent Attachment Bolts Due to Interference Risk
OrthoPediatrics Corp is recalling 211 units of Adolescent attachment bolts used with the Pediatric Nailing Platform. The recall is due to potential interference between the bolt and nail, which may delay surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (surgical delay) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
OrthoPediatrics Corp is recalling 211 units of the Adolescent attachment bolt, part number 01-1503-0032. This component is used with the Pediatric Nailing Platform (PNP) targeting arm to attach the targeting arm to the intramedullary fixation rod. The affected units were distributed nationwide and in Australia.
The recall was initiated because interference can occur between the adolescent attachment bolt and the adolescent nail. This interference may cause a delay in surgical procedures. The recall is classified as Class II by the FDA.
Healthcare providers and facilities that have received these devices should stop using them and contact OrthoPediatrics Corp for further instructions. Consumers are not directly affected as this is a professional medical device used in surgical settings.
The recalled product
- Product
- OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system (bolt is used to attach the targeting arm to the intramedullary fixation rod) Part number: 01-1503-0032
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 211
Distribution
Distributed nationwide across the United States.
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