The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1535-2013·Announced 2013-06-19

OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

OrthoPediatrics Corp is recalling 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 a structural defect (bending) that poses a risk of harm during surgery, but no injuries or illnesses have been reported, fitting the 'High' severity criteria.

Plain-English summary

OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates (Catalog No. 00-1200-1001). The recall involves 130 devices that were distributed nationwide in the United States. All lot numbers are affected.

The recall was initiated following post-market surveillance that identified five reports of the plates bending intra-operatively. The OrthoPediatrics Locking Cannulated Blade Plate System is intended for the fixation of long bone fractures and osteotomies in pediatric patients (excluding neonates) and small stature adults.

Healthcare providers should stop using the affected devices and contact OrthoPediatrics Corp for further instructions on the recall.

The recalled product

Product
90 Degree Cannulated Infant Blade Plate 30mm 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
Category
Medical Device — Orthopedic Implant
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. 00-1200-1001

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.

See all 3 products in this recall →

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