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Recall Observatory FDA recall evidence

Device product

ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.

Z-0826-2013

January 28, 2013

Class II

Product summary

Firm
ConMed Corporation
Event
Event 64248
Status
Terminated
Classification
Class II
Quantity
Domestic Distribution: 97,450 units; Foreign Distribution: 6,800 units
Official record key
device-enforcement:Z-0826-2013

Official wording

Reason: Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.

Code information: Beginning Lot Code 120628X, Ending Lot Code 120917X. [Lot codes on boxes and packaging contain a lot code in the following format: 120917X where 12 represents the year (2012), 09 represents the month (September), 17 represents the day of the month, and X represents the manufacturing shift code (1, 2, 3, 4,5,6 or 9)].

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    pouch. ConMed confirmed instances where the pouch seal was compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterile pouch. ConMed confirmed instances where the pouch seal was compromised