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PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604… recallZ-1610-2014 · Ortho Development Corporation · initiated Apr 1, 2014

Class II Terminated All recalls posted in May 2014

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 Ortho Development Corporation 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

A femoral component containing pegs was found in a box for the pegless version.

FDA root cause category: Process control

What the company is doing

Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.

Recall details

Recall number
Z-1610-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 1, 2014
Posted by the FDA
May 13, 2014
Recalling firm
Ortho Development Corporation
Quantity
5
Product code
JWH
FDA submissions
K994370
Distribution
US Nationwide Distribution in the states of NV, and AZ.

Product description

PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

Code information (models, lots, serial numbers)

Lot No. A131876

Other devices under the same FDA submission

4 devices cleared under K994370 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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