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Recall Observatory FDA recall evidence

Device product

GII QuickAnchor Plus, ETHIBOND Polyester Suture, 36", double-Armed w/CP 2 Needles 2. Ref. 212034 Lot 123266 General and Plastic Surgery

Z-1626-2013

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-1626-2013

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: 123266

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile barrier for reprocessed medical devices became compromised