FDA Medical Device Recalls (openFDA)
PIONEER SURGICAL TECHNOLOGY, INC.: STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
- Recall number
- Z-2573-2014
- Recalling firm
- PIONEER SURGICAL TECHNOLOGY, INC.
- Product
- STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY
- Status
- Terminated
- Initiated
- 2012-09-10
- Posted
- 2014-09-03
- Terminated
- 2014-09-30
- Reason
- Some set screw thread profiles were found not to be within specifications.
- Root cause
- Nonconforming Material/Component
- Action
- The recall took place at the distributor/sales representative level. Communication was done through phone and email notifications on 9/10/2012. All affected set screws were to be traded out through a scheduled process. This was coordinated through Pioneer Surgical's customer service. Product was scrapped and no reconditioning took place. All affected set screws were swapped out.
- Quantity
- 11 sets
- Distribution
- Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.
- Lot, serial or model codes
- Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.
- 510(k) numbers
- ["K112757"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 1000115331
- Firm city
- Marquette
- Firm state
- MI
- 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