Z-0086-2010

Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head

Name: Z-0086-2010 Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head
Creator: Ortho Development Corporation
Published: 2009-04-29
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2009-04-29 / Terminated / root cause: design

FDA source

Ortho Development Corporation began a recall of Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head on 2009-04-29. The reason FDA records is "A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0086-2010
Status: Terminated
Initiated: 2009-04-29
Posted: 2009-10-28
Terminated: 2010-05-25
Recalling firm: Ortho Development Corp.
Product: Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
Product code: KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Reason for recall: A Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.
Root cause tag: design
FDA root cause: Device Design
Action: Ortho sent a Field notification Memo dated 4/2/2009 to agents and distributors, giving them pre-implant examination guidelines. Decision to recall non-implanted units was made on 4/29/2009 and this was communicated by telephone to distributors.
Quantity in commerce: 23
Distribution: AZ, CA, FL, MA, MI. No military, government or foreign distribution.
Product codes and lots: Part 133-2846, Lots 3370, 3534, 3620, 3731 Part 133-2847, Lots 3492, 3535 Part 133-2848, Lot 3509 Part 133-2851, Lot 3433 Part 133-2852, Lot 3661

Product code KWY

K050966Class IIPivot Bipolar Femoral HeadOrtho Development Corp. / cleared 2005-07-07

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)