FDA Medical Device Recalls (openFDA)
Ortho Development Corporation: Distal Centralizer 10 mm
- Recall number
- Z-0315-2011
- Recalling firm
- Ortho Development Corporation
- Product
- Distal Centralizer 10 mm
- Status
- Terminated
- Initiated
- 2010-07-28
- Posted
- 2010-11-03
- Terminated
- 2010-11-04
- Reason
- The hip stem did not fit the distal centralizer because the hole was not drilled with the appropriate taper.
- Root cause
- Nonconforming Material/Component
- Action
- Ortho Development sent a Field Notification Memo dated July 28, 2010 to Japan Medical Dynamic Marketing instructing them to reconcile parts that may have been used and return unused parts to Ortho. Customers can contact Ortho Development at 1-801-619-3419.
- Quantity
- 39 units
- Distribution
- Worldwide Distribution: Japan
- Lot, serial or model codes
- Work order numbers: 0050794; 0051535; 0054967; 0055667; 0060372; 0061102; 0061769; 0062929; 0063395
- 510(k) numbers
- ["K962448"]
- 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