OrthoPediatrics Recalls Mislabeled 3.5mm Bowed Locking Compression Femur Plates
OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates due to mislabeling.
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 involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
OrthoPediatrics Corp is voluntarily recalling 41 units of 3.5mm Bowed Locking Compression Femur Plates, specifically the 14-hole and 18-hole models. The recall is being conducted because the devices were mislabeled.
The affected products are identified by Product Number 00-1050-3214 and Lot Numbers NM02341 and NM02342. These devices were distributed nationwide to facilities in Arizona, California, Colorado, Delaware, Florida, Georgia, Kentucky, Michigan, Minnesota, Missouri, Rhode Island, New York, Ohio, Oregon, Tennessee, Texas, Virginia, and Washington. There was no foreign distribution or distribution to VA/DOD facilities.
Healthcare providers and facilities should stop using the affected lots and contact OrthoPediatrics Corp for further instructions regarding the return or replacement of the mislabeled devices.
The recalled product
- Product
- 3.5mm Bowed Locking Compression Femur Plates, 14 hole Orthopediatrics PediLoc Locking Plate System comes in sets that offer the advantage of both conventional and locking plate fixation devices and instrumentation in one system. Utilizing both locking and non- locking screws…
- Manufacturer
- OrthoPediatrics Corp
- Hazard
- Affected units
- 41
Distribution
Part of a larger recall action
This product is one of 2 recalled by OrthoPediatrics Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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