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Ovation Hip Stem, REF 201-0104, Offset Stem Inserter… recallZ-1673-2011 · Ortho Development Corporation · initiated Jan 11, 2011

Terminated All recalls posted in March 2011

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

Component of total hip arthroplasty may break during surgical procedure.

FDA root cause category: Process design

What the company is doing

Ortho Development Corporation notified Field representatives of the issue and conditions that could lead to failure by e-mail on December 14, 2010. Redesigned product is being produced for replacement. For questions regarding this recall call 801-619-3450.

Recall details

Recall number
Z-1673-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 11, 2011
Posted by the FDA
Mar 16, 2011
Recalling firm
Ortho Development Corporation
Quantity
33 units
Product code
LZO
FDA submissions
K062775
Distribution
Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.

Product description

Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an instrument used to seat the hip stem in the femur. There is a notch in the top of the hip stem, and the hip stem inserter has a corresponding tip at the end of the instrument. The tip of the inserter is designed to fit into the notch of the hip stem, as a guide. Once this is inserted, the surgeon will tap on the opposite end of the inserter with a hammer to seat the press-fitted stem assembly.

Code information (models, lots, serial numbers)

All lots

Other devices under the same FDA submission

5 devices cleared under K062775 — 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 57747).

Sources and updates

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