Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001,
FDA device recall Z-1839-2014 · posted 2014-06-20 · Terminated
Recall details
- Recalling firm
- ConMed Corporation
- Reason for recall
- ConMed Corporation initiated an Urgent Medical Device Correction for Altrus Thermal Tissue Fusion Handpieces due to risk of burns.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 12,653 units (10,769 domestically & 1,884 internationally)
- Distribution
- Worldwide Distribution.
- Date initiated
- 2014-02-20
- Date posted
- 2014-06-20
- Date terminated
- 2017-04-07
- Location
- Utica, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM (K101534) | Conmedcorp | 2010-11-24 |