FDA Medical Device Recalls (openFDA)
Orthohelix Surgical Designs Inc: MaxTorque Cannulated Screw Model # MSD-010-55-060S
- Recall number
- Z-1250-2010
- Recalling firm
- Orthohelix Surgical Designs Inc
- Product
- MaxTorque Cannulated Screw Model # MSD-010-55-060S
- Status
- Terminated
- Initiated
- 2009-04-07
- Posted
- 2010-04-06
- Terminated
- 2010-10-20
- Reason
- A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.
- Root cause
- Other
- Action
- On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification. For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209.
- Quantity
- 45 pieces
- Distribution
- Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA.
- Lot, serial or model codes
- Model # MSD-010-55-060S
- 510(k) numbers
- ["K060428"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3000718467
- Firm city
- Medina
- Firm state
- OH
- 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