Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 10 mm O.D., 23 cm Shaft, Catalog Number 60-9511-001, Sterile/EO. T
FDA device recall Z-1682-2012 · posted 2012-05-29 · Terminated
Recall details
- Recalling firm
- ConMed Electrosurgery
- Reason for recall
- The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
- Action taken
- ConMed Electrosurgery sent an "URGENT: DEVICE RECALL" letter dated May 2, 2012 to all affected customers. The letter identifies the product, problem,and actions to be taken by the customers. The letter instructs customers to review their inventory and to complete and return a Business Reply Form via fax to 303-699-9854.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 36 units
- Distribution
- Class II Recall-Nationwide Distribution-including the states of OH, GA, IL, PA, AZ, KY, FL, NY, MO, TN, TX, AL, IN, SC, MD, CT, NJ, and CA.
- Date initiated
- 2012-05-07
- Date posted
- 2012-05-29
- Date terminated
- 2012-06-05
- Location
- Centennial, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM (K101534) | Conmedcorp | 2010-11-24 |