Pioneer Surgical brand Quantum Spinal Rod System Locking Cap; Catalog No 10-LCAP.
FDA Recall Z-1457-05 · Posted 2005-08-31
Recalling FirmPioneer Surgical Technology
Recall StatusTerminated
Product CodeMVH
Date Initiated2005-07-29
Date Terminated2005-10-25
Product Quantity5069
Reason for Recall
The product has a higher than normal locking torque, which may cause the saddle to malfunction or to break interoperatively.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.