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Recall Observatory FDA recall evidence

Device product

Large Tear Cross Cut Rasp 14mm x 7mm Ref. 5100-37-114 Lot 122347 Manual surgical instrument for general use

Z-1634-2013

May 03, 2013

Class II

Product summary

Firm
Surgical Instrument Service And Savings, Inc.
Event
Event 65205
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-1634-2013

Official wording

Reason: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.

Code information: 122347

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier for reprocessed medical devices became compromised