Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip… recallZ-0086-2010 · Ortho Development Corporation · initiated Apr 29, 2009
Terminated All recalls posted in October 2009
Is my device affected?
- 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.
- 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.
- 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 Pivot BiPolar Head, the femoral head in a hip prosthesis, might not move freely after assembly due a stacking up of manufacturing tolerances.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0086-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Apr 29, 2009
- Posted by the FDA
- Oct 28, 2009
- Recalling firm
- Ortho Development Corporation
- Quantity
- 23
- Product code
- KWY
- FDA submissions
- K050966
- Distribution
- AZ, CA, FL, MA, MI. No military, government or foreign distribution.
Product description
Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
10 devices cleared under K050966 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Pivot Bipolar 133-2244Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- Pivot Bipolar 133-2251Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 reports
- Pivot Bipolar 133-2241Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2242Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2243Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2245Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2246Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2847Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2852Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
- Pivot Bipolar 133-2853Ortho Development Corporation · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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