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 devices were distributed nationwide to specific states.
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 voluntary precautionary recall for mislabeling, which aligns with the Moderate severity criteria for minor labeling errors.
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, due to the devices being mislabeled. The affected product is identified by Product Number 00-1050-3218 and Lot Number NM02346.
The recalled devices were distributed nationwide to Arizona, California, Colorado, Delaware, Florida, Georgia, Kentucky, Michigan, Minnesota, Missouri, Rhode Island, New York, Ohio, Oregon, Tennessee, Texas, Virginia, and Washington. No foreign or VA/DOD distribution is reported.
Consumers and healthcare providers should stop using the affected devices and contact OrthoPediatrics Corp for further instructions.
The recalled product
- Product
- 3.5mm Bowed Locking Compression Femur Plates, 18 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
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: 00-1050-3218 Lot Number: NM02346
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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