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Terminated

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

FDA Recall Z-0021-06 · Posted 2005-10-07

Recalling FirmPioneer Surgical Technology
Recall StatusTerminated
Product CodeNKB
Date Initiated2005-07-29
Date Terminated2005-10-25
Product Quantity124

Reason for Recall

Screw may be incorrectly etched as to length.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041167PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEMPioneer Surgical Technology · 2004-07-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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