ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, STERILE -- CONMED CORPOR

FDA device recall Z-0332-2014 · posted 2013-11-15 · Terminated

Recall details

Recalling firm

ConMed Corporation

Reason for recall

The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.

Action taken

The firm, ConMed, sent an "URGENT: VOLUNTARY DEVICE RECALL" letter dated October 23, 2013 and Business Reply Forms to the domestic consignees/customers via USPS Priority Mail. Distribution of the recall letter to the foreign consignees will follow once the letter has been translated into the different foreign languages. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop the use of these devices; review your inventory for any of the devices listed; contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to; complete and return the ATTACHMENT I Effectiveness Check Business Reply Form via fax to: ConMed Recall Coordinator at 315-624-3225. If you have any of the affected devices, please complete Attachment I and return it with the devices to: ConMed Corporation, 525 French Road, Utica, NY 13502 Attn. Ed Kovac, Return via: FedEx Account # 487553646. Please indicate with your returned devices, if you are requesting credit or replacement of the devices. Please do not return used devices. If you do not have any devices to return, please complete Attachment I, indicating you have no devices and fax it to 315-624-3225, Attn: ConMed Recall Coordinator. For questions, please contact ConMed Recall Coordinator at 315-624-3237 or e-mail altrus@conmed.com.

Root cause

Material/Component Contamination

Status

Terminated

Product code

GEI

Quantity affected

147 handpieces (Domestic: 135 devices; Foreign: 12 devices)

Distribution

Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy.

Date initiated

2013-10-23

Date posted

2013-11-15

Date terminated

2017-03-08

Location

Utica, NY

Related 510(k) clearances