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Z-2573-2014 Class II Terminated

Recalled by PIONEER SURGICAL TECHNOLOGY, INC. — Marquette, MI

FDA device recall Z-2573-2014 was initiated by PIONEER SURGICAL TECHNOLOGY, INC. on September 10, 2012 and is designated Class II. Reason for recall: Some set screw thread profiles were found not to be within specifications. The recall status is terminated (terminated September 30, 2014). Affected quantity: 11 sets.

Recall Details

Product Type: Devices
Report Date: September 10, 2014
Initiation Date: September 10, 2012
Termination Date: September 30, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 11 sets

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

Lot numbers: 104875, 104876, 104877, 104878, 104879, 104880, 104881 , 117030,117031 , 121947, 124260.