Reported Oct 23, 2019 · Terminated
OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an…
OrthoPediatrics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OrthoPediatrics Corp · 2850 Frontier Dr · Warsaw, IN · 46582-7001
Is this the product you have?
- 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 number01-1503-0032
- Lot codes and dates
- Lot/serial number
192432-B192279-B189808-A187375-A177577-A183280-A175221-A174784-A
- UDI00841132149836
- Lot/serial number
- Amount recalled
- 211 units
Where it was sold
- Nationwide
Why it was recalled
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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