FDA Medical Device Recalls (openFDA)
ConMed Electrosurgery: Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
- Recall number
- Z-1681-2012
- Recalling firm
- ConMed Electrosurgery
- Product
- Altrus Thermal Tissue Fusion, Tissue Fusion Handpiece 5 mm O.D., 16 cm Shaft, Catalog Number 60-9520-001, Sterile/EO. The Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece.
- Status
- Terminated
- Initiated
- 2012-05-07
- Posted
- 2012-05-29
- Terminated
- 2012-06-05
- Reason
- The devices were distributed prior to the firm completing performance qualifications for their package sealing and adhesive bonding.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 18 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.
- Lot, serial or model codes
- Lot codes: 11AHB005, 11DHB005.
- 510(k) numbers
- ["K101534"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 3004491689
- Firm city
- Centennial
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28