OrthoPediatrics Recalls 3.5mm Non Locking Cortical Screws Due to Packaging Error
OrthoPediatrics Corp is recalling 3.5mm Non Locking Cortical Screws because the packaging may contain a different screw size than labeled.
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. The hazard is a labeling/packaging error where the wrong screw size is included in the package, which is a moderate risk of harm but does not meet the criteria for severe injury or critical failure.
Plain-English summary
OrthoPediatrics Corp is recalling 3.5mm Non Locking Cortical Screws, part number 00-0903-2510, used in the PediLoc Tibial Plate System for pediatric orthopedics. The recall involves 5 units from lot number 150192-J.
The recall was initiated because the package for the 3.5mm x 10mm screw may contain a different screw. Specifically, the screw inside the package is a 00-0903-2526, 3.5mm x 26mm screw, which is etched correctly but does not match the package label.
The affected units were distributed domestically to Tennessee and Iowa, and internationally to England. No units were distributed to VA/DOD facilities. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
- Manufacturer
- OrthoPediatrics Corp
- Affected units
- 5
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 (2)
- Part number 00-0903-2510
- Lot number 150192-J
Distribution
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