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Recall Observatory FDA recall evidence

Device product

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

Z-2573-2014

September 10, 2012

Class II

Product summary

Firm
PIONEER SURGICAL TECHNOLOGY, INC.
Event
Event 69033
Status
Terminated
Classification
Class II
Quantity
11 sets
Official record key
device-enforcement:Z-2573-2014

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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