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90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole recallZ-1536-2013 · OrthoPediatrics Corp · initiated Apr 19, 2013

Class II Terminated All recalls posted in June 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from OrthoPediatrics Corp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

FDA root cause category: Device Design

What the company is doing

OrthoPediatrics sent an Urgent Voluntary Recall notifiation via telephone and email to all affected consignees. The letter instructed consignees to take possession of any affected devices and quarantine immediately. A Mandatory Reply Form is included with the notification letter to be completed and returned. Please contact Greg Teghtmeyer if you have any questions (574-268-6379).

Recall details

Recall number
Z-1536-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 19, 2013
Posted by the FDA
Jun 12, 2013
Recalling firm
OrthoPediatrics Corp
Quantity
130 devices were shipped
Product code
HWC
FDA submissions
K110959
Distribution
USA Nationwide Distribution

Product description

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. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.

Code information (models, lots, serial numbers)

All lot numbers are affected. Catalog No. 00-1200-1002

Other devices under the same FDA submission

15 devices cleared under K110959 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 65091).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page