Arthroscopic Energy 50 Probe with Suction, Catalog number: AES-50S Peoduct Usage: For resection, ablation, and coagulati
FDA device recall Z-0205-2016 · posted 2015-11-03 · Terminated
Recall details
- Recalling firm
- ConMed Corporation
- Reason for recall
- Probe programming error. The incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
- Action taken
- On June 17, 2015 Con Med Corporation distributed Urgent Device Recall Notification Letters and Recall Reply forms to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory for any of the affected lot numbers referenced on the recall notice. If any of the recalled product are in stock, customers should discontinue the use or distribution of these items. If product was further distributed, customers should notify those individuals of this recall action. Customers with questions can call Gregory Connell at 727-399-5276 or email AES50S@conmed.com. Customers should also complete and return the Recall Reply Form by mail to the address listed on the recall notice.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 276 devices
- Distribution
- Worldwide - US distribution in the states of FL, OH, and the country of Spain.
- Date initiated
- 2015-06-17
- Date posted
- 2015-11-03
- Date terminated
- 2017-04-11
- Location
- Utica, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROSCOPIC ENERGY SYSTEM (K140578) | Conmed Corporation | 2014-07-23 |