Z-1457-05

Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP

Name: Z-1457-05 Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP
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 Locking Cap; Catalog No 10-LCAP on 2005-07-29. The reason FDA records is "The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1457-05
Status: Terminated
Initiated: 2005-07-29
Posted: 2005-08-31
Terminated: 2005-10-25
Recalling firm: RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Product: Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.
Product code: MVH Device, Detection, Sulfide
Reason for recall: The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.
FDA root cause: Other
Action: Distributors were notified via letter dated July 29, 2005 to retrieve all caps from inventory and point of use locations and to return them to Pioneer.
Quantity in commerce: 5069
Distribution: Nationwide.
Product codes and lots: Lots 306456, 306457, 306613, 306712, 306713, 306714, 306816, 306817, 306818, 306819, 306820, 306821, 306822, 307526, 307527, 307528, 307667, 307668, 308510, 308938, 310662, 310663, 310664, 310665, 311718, 312169, 519935 and 521042.

Product code MVH

K041156Class IIAvant Digital Pulse Oximetry System, Models 4000, 4001Nonin Medical, Inc. / cleared 2004-06-09

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)