Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
FDA Recall Z-0291-2008 · Posted 2007-11-27
Recalling FirmPioneer Surgical Technology
Recall StatusTerminated
Product CodeHWR
Date Initiated2007-10-10
Date Terminated2008-03-31
Product Quantity38
Reason for Recall
The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
Firm 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.
Root Cause
Component change control
Distribution Pattern
Nationwide: including states of California, Florida, Michigan and North Carolina.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.