Z-0021-06

Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40

Name: Z-0021-06 Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40
Creator: Pioneer Surgical Technology
Published: 2005-07-29
License: https://open.fda.gov/license/

RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) / initiated 2005-07-29 / Terminated

FDA source

Pioneer Surgical Technology began a recall of Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40 on 2005-07-29. The reason FDA records is "Screw may be incorrectly etched as to length". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0021-06
Status: Terminated
Initiated: 2005-07-29
Posted: 2005-10-07
Terminated: 2005-10-25
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Screw may be incorrectly etched as to length.
FDA root cause: Other
Action: Consignees were notified by letter dated 7/29/05 to inspect stocks in storage and at point of use locations hand for correct length and that a firm representative would visit them to pick up any mis-etched product.
Quantity in commerce: 124
Distribution: Nationwide.
Product codes and lots: Lot 308623.

Product code NKB

K041167Class IIPioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology / cleared 2004-07-23

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)