OrthoPediatrics PediNail Cortical Screw Recalled for Dimensional Discrepancy
OrthoPediatrics is recalling 22 PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screws because they measure 50mm instead of the labeled 48mm.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a dimensional labeling discrepancy without reported injuries.
Plain-English summary
OrthoPediatrics Corp is recalling 22 units of the PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw. The recall is due to a labeling error where the screws are labeled as 48mm but actually measure 50mm.
The affected product is identified by Product Number 10-1500-3048 and Lot Number 161421-G. The devices were distributed worldwide, including in the United States to the states of Texas, Missouri, Florida, Georgia, North Carolina, Arizona, and New York, as well as to France and Ireland.
Healthcare providers and consumers should stop using the affected screws and contact OrthoPediatrics Corp for further instructions.
The recalled product
- Product
- OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
- Manufacturer
- OrthoPediatrics Corp
- Hazard
- Affected units
- 22
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)
- Product Number: 10-1500-3048 Lot Number: 161421-G
Distribution
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