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Terminated

STREAMLINE CT CERVICO-THORACIC SYSTEM; SET SCREW REF 26-SETSCREW NON-STERILE, SINGLE USE, RX ONLY

FDA Recall Z-2573-2014 · Posted 2014-09-03

Recalling FirmPIONEER SURGICAL TECHNOLOGY, INC.
Recall StatusTerminated
Product CodeKWP
Date Initiated2012-09-10
Date Terminated2014-09-30
Product Quantity11 sets

Reason for Recall

Some set screw thread profiles were found not to be within specifications.

Firm Action

The recall took place at the distributor/sales representative level. Communication was done through phone and email notifications on 9/10/2012. All affected set screws were to be traded out through a scheduled process. This was coordinated through Pioneer Surgical's customer service. Product was scrapped and no reconditioning took place. All affected set screws were swapped out.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in the states of NC, NH, NY, CA, MI, IL, and FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112757PIONEER POSTERIOR CERVICO THORACIC SYSTEMPioneer Surgical Technology, Inc. · 2012-03-12

Official Source

View FDA Recall →

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

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