OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates
OrthoPediatrics Corp is recalling 130 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with reported mechanical failure (bending) during surgery, which poses a risk of harm, but the source text does not explicitly report injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
OrthoPediatrics Corp is recalling 130 units of the 90 Degree Cannulated Infant Blade Plate (Catalog No. 00-1200-1002). The device is intended for the fixation of long bone fractures and osteotomies in pediatric patients and small stature adults. The recall covers all lot numbers of this specific catalog item.
The recall was initiated following post-market surveillance that identified five reports of the plate bending intra-operatively. The devices were distributed nationwide in the United States.
Healthcare providers should stop using the affected devices and contact OrthoPediatrics Corp for further instructions regarding the recall.
The recalled product
- Product
- 90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults.…
- Manufacturer
- OrthoPediatrics Corp
- Hazard
- Affected units
- 130
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)
- All lot numbers are affected. Catalog No. 00-1200-1002
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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