FDA Medical Device Recalls (openFDA)
Orthohelix Surgical Designs Inc: CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
- Recall number
- Z-0466-2011
- Recalling firm
- Orthohelix Surgical Designs Inc
- Product
- CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
- Status
- Terminated
- Initiated
- 2010-10-15
- Posted
- 2010-11-26
- Terminated
- 2012-09-06
- Reason
- The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This
- Root cause
- Device Design
- Action
- OrthoHelix issued an Important Recall Notice letter dated October 15, 2010 to their customers, identifying the affected products. Customers were requested to immediately return the afected devices. OrthoHelix can be contacted at 330 247-1444 concerning this recall.
- Quantity
- 2
- Distribution
- Nationwide distribution: to the states of GA and MO.
- Lot, serial or model codes
- CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031
- 510(k) numbers
- ["K060428"]
- PMA numbers
- not on file
- Product code
- HWX
- 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