Z-1670-2011

Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020. The...

Name: Z-1670-2011 Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020. The...
Creator: Ortho Development Corporation
Published: 2011-01-11
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2011-01-11 / Terminated / root cause: manufacturing process

FDA source

Ortho Development Corporation began a recall of Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020. The Ovation Hip System is intended for use in total hip... on 2011-01-11. The reason FDA records is "Component of total hip arthroplasty may break during surgical procedure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1670-2011
Status: Terminated
Initiated: 2011-01-11
Posted: 2011-03-16
Terminated: 2011-11-04
Recalling firm: Ortho Development Corp.
Product: Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, 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.
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Reason for recall: Component of total hip arthroplasty may break during surgical procedure.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 33 units
Distribution: Nationwide Distribution including AZ, CA, CO, FL, MI, NV, OR, and UT.
Product codes and lots: All lots

Product code LZO

K062775Class IIEuropean Style Taper,press-Fit Hip StemOrtho Development Corp. / cleared 2007-01-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)