Z-0291-2008

Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer...

Name: Z-0291-2008 Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer...
Creator: Pioneer Surgical Technology
Published: 2007-10-10
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2007-10-10 / Terminated

FDA source

Pioneer Surgical Technology began a recall of Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855 on 2007-10-10. The reason FDA records is "The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0291-2008
Status: Terminated
Initiated: 2007-10-10
Posted: 2007-11-27
Terminated: 2008-03-31
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: Pioneer Quantum Spinal Rod System, MIS Yoke Manipulator, Long Slot, non-sterile; Cat # 51-YOKEMAN-L, Pioneer Surgical Technology, Marquette, MI 49855
Product code: HWR Driver, Prosthesis
Reason for recall: The pins may come out of the instrument and, if this happens, they could fall into/remain in the patient.
FDA 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 in commerce: 38
Distribution: Nationwide: including states of California, Florida, Michigan and North Carolina.
Product codes and lots: Lot 013886.

Product code HWR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)