Recalls / —
—#115662
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.
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K800617
- Affected lot / code info
- 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)].
Why it was recalled
Some devices had broken through the seal of the sterile pouch. ConMed confirmed instances where the pouch seal was compromised on the affected products.
Root cause (FDA determination)
Equipment maintenance
Action the firm took
ConMed sent Urgent Device Recall Letters (dated 1/28/13) and Business Reply Forms to all domestic customers via USPS Priority Mail. International notices were sent via FedEx International Priority to the foreign consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory and complete Attachment II response form and return it with unused affected product to: ConMed Corporation 525 French Road, Utica, NY 13502. Customers were asked to return Attachment II even if they don't have any affected product. For questions regarding this recall call 315-624-3533.
Recalling firm
- Firm
- ConMed Corporation
- Address
- 525 French Road, Utica, New York 13502
Distribution
- Distribution pattern
- Worldwide Distribution-USA (nationwide) and the countries of China, Dubai and Indonesia.
Timeline
- Recall initiated
- 2013-01-28
- Posted by FDA
- 2013-02-15
- Terminated
- 2017-04-11
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #115662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.