FDA Medical Device Recalls (openFDA)
Orthohelix Surgical Designs Inc: MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.
- Recall number
- Z-0598-06
- Recalling firm
- Orthohelix Surgical Designs Inc
- Product
- MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.
- Status
- Terminated
- Initiated
- 2005-11-01
- Posted
- 2006-03-09
- Terminated
- 2012-04-25
- Reason
- Screwdriver pilot taper tip can break during surgery.
- Root cause
- Other
- Action
- Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product.
- Quantity
- 14
- Distribution
- Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida.
- Lot, serial or model codes
- lot #11298
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3000718467
- Firm city
- Akron
- 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