Recalls / —
—#125832
Product
Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm Catalog Number 60-9521-001 and 6) 5 mm x 36 cm Catalog Number 60-9522-001. Products are packaged within cartons, 6 units per carton.
- FDA product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class 2
- Medical specialty
- General, Plastic Surgery
- 510(k) numbers
- K101534
- Affected lot / code info
- all lot codes
Why it was recalled
ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
Root cause (FDA determination)
Device Design
Action the firm took
On February 20, 2014 and February 28, 2014 ConMed Corporation distributed Urgent Medical Device Correction notices to their domestic and foreign customers via FedEx Priority. The notice was generated by ConMed for information purposes only. Customers are to ensure that the jaws of the energy vessel sealing device does not come in contact with unintended tissue, surfaces, or objects until the jaws have cooled sufficiently. Customers who have further distributed this product, please forward a copy of the correction notice to the recipient as appropriate. Customers will questions should contact ConMed Regulatory Affairs at (315) 624-3237 or by email at altrus@conmed.com.
Recalling firm
- Firm
- ConMed Corporation
- Address
- 525 French Road, Utica, New York 13502
Distribution
- Distribution pattern
- Worldwide Distribution.
Timeline
- Recall initiated
- 2014-02-20
- Posted by FDA
- 2014-06-20
- Terminated
- 2017-04-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #125832. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.