Recall Z-1839-2014— ConMed Corporation
Class II · Terminated
Class II FDA medical device recall by ConMed Corporation, initiated 2014-02-20, terminated 2017-04-07. It names one FDA 510(k) clearance: K101534. 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.. Reason: ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns..
- Recalling firm
- ConMed Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-20
- Terminated
- 2017-04-07
- Firm location
- Utica, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
Data sourced from openFDA. This site is unofficial and independent of the FDA.