OrthoPediatrics PediLoc Locking Plate System Recalled for Incorrect Left-Right Labeling
OrthoPediatrics Corp is recalling 15 PediLoc Locking Plate System devices because they are left-sided plates incorrectly labeled and etched as right-sided.
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, and the hazard is a labeling error (left vs. right) without reported injuries or illnesses, fitting the criteria for moderate severity involving minor labeling errors or low-risk contamination.
Plain-English summary
OrthoPediatrics Corp is recalling 15 units of the PediLoc Locking Plate System, specifically the 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. The devices are used for pediatric patients with pelvic, small, and long bone fractures.
The recall was initiated because the devices are physically left-sided plates but are incorrectly labeled and etched as right-sided devices. This labeling error could lead to the use of the wrong implant orientation during surgery.
The affected devices have lot number 7736703 and part number 00-1050-4308. Distribution was worldwide, including the United States (specifically Indiana, Georgia, Michigan, Florida, Missouri, Ohio, and South Carolina) and Australia. Healthcare providers should stop using these devices and contact OrthoPediatrics Corp for instructions on return or replacement.
The recalled product
- Product
- OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
- Manufacturer
- OrthoPediatrics Corp
- Hazard
- Affected units
- 15
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)
- Lot number: 7736703 and part number: 00-1050-4308
Distribution
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