FDA Medical Device Recalls (openFDA)
Pioneer Surgical Technology: Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
- Recall number
- Z-0291-2008
- Recalling firm
- Pioneer Surgical Technology
- Product
- Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
- Status
- Terminated
- Initiated
- 2007-10-10
- Posted
- 2007-11-27
- Terminated
- 2008-03-31
- Reason
- The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
- Root cause
- Component change control
- Action
- Consignees were notified via a Product Recall letter dated 10/10/07 to remove these instruments from their instrument cases and to return them to the firm.
- Quantity
- 38
- Distribution
- Nationwide: including states of California, Florida, Michigan and North Carolina.
- Lot, serial or model codes
- Lot 013886.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWR
- 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