FDA Medical Device Recalls (openFDA)
Ortho Development Corporation: Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
- Recall number
- Z-0086-2010
- Recalling firm
- Ortho Development Corporation
- Product
- Ortho Development Corp., Pivot BiPolar Head, 28mm, Hip Prosthesis, Femoral Head.
- Status
- Terminated
- Initiated
- 2009-04-29
- Posted
- 2009-10-28
- Terminated
- 2010-05-25
- Reason
- 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
- 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
- 23
- Distribution
- AZ, CA, FL, MA, MI. No military, government or foreign distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K050966"]
- PMA numbers
- not on file
- Product code
- KWY
- Firm FEI
- 3017298928
- Firm city
- Draper
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28