Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Te
FDA device recall Z-0291-2008 · posted 2007-11-27 · Terminated
Recall details
- Recalling firm
- Pioneer Surgical Technology
- Reason for recall
- The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
- Action taken
- 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.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- HWR
- Quantity affected
- 38
- Distribution
- Nationwide: including states of California, Florida, Michigan and North Carolina.
- Date initiated
- 2007-10-10
- Date posted
- 2007-11-27
- Date terminated
- 2008-03-31
- Location
- Marquette, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.