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Recall Observatory FDA recall evidence

Device product

TPS Micro Reciprocating Small Tear Cross Cut Rasp 5.0mm x 11mm Ref. 5100-37-113 Lot 122518, 122447. Orthopedic manual surgical instrument

Z-1637-2013

May 03, 2013

Class II

Product summary

Firm
Surgical Instrument Service And Savings, Inc.
Event
Event 65205
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-1637-2013

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: 122518, 122447.

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier for reprocessed medical devices became compromised