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Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt… recallZ-0364-2010 · Orthopediatrics Corp · initiated Jul 21, 2009

Terminated All recalls posted in May 2010

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

The potential exists for the nails to fracture during insertion of the nail.

FDA root cause category: Device Design

What the company is doing

Distributor consignees were notified by email dated July 28, 2009 and requested to return the recalled products and instrument sets. If there are questions regarding this issue, please contact Gary Barnett at 574-268-6379.

Recall details

Recall number
Z-0364-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 21, 2009
Posted by the FDA
May 12, 2010
Recalling firm
Orthopediatrics Corp
Quantity
23 of all products
Product code
HSB
FDA submissions
K083726
Distribution
Nationwide.

Product description

Orthopediatrics IM Femoral Nail - 8mm x 36 cm, Lt, non-sterile, Orthopediatrics, Warsaw, IN; Part # 10-1500-087. The system is used for pediatric and small stature adult patients to stabilize fractures of the femoral shaft, subtrochanteric fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions and malunions, fixation of femurs that have been surgically prepared for correction of deformity.

Code information (models, lots, serial numbers)

Lots 105491 and 105492.

Other devices under the same FDA submission

3 devices cleared under K083726 — 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 52852).

Sources and updates

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