| | Class 3 Recall
Advantage Drive System |  |
| Date Posted |
March 06, 2013 |
| Recall Number |
Z-0916-2013 |
| Product |
D3000 Advantage Drive System, 115v
Product Usage: The Advantage Drive Systems function as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone |
| Code Information |
Model #D3000
|
Recalling Firm/
Manufacturer |
Linvatec Corp. dba ConMed Linvatec
11311 Concept Blvd
Largo, Florida 33773-4908 |
| For Additional Information Contact |
Roger Murphy
727-399-5205
|
Reason for
Recall |
The Membrane Switch Panel (referred to as "front panel" of the component part number A34-003-207, used on both the D3000 and D3000I Advantage Drive System, contained the incorrect symbology per third edition IEC60606-01 Medical Electrical Equipment: General requirements for basic safety and essential performance.
|
| Action |
Linvatec Corp sent an "URGENT: Medical Device Recall Notification" letter dated January 24, 2013 to its customers after initial phone notifications. The letter describes the affected product, problem and actions to be taken. Customers were instructed to immediate check facility's inventory for the affected product, use the enclosed FedEx air-bill when returning the product, and complete and return to the Recall Reply Form. For questions contact your Customer Service department at 800-535-8536 or fax at 727-319-5701 or email Custserv1@linvatec.com. |
| Quantity in Commerce |
31 units |
| Distribution |
Worldwide Distribution - USA (nationwide) including the states of: CA, FL, GA, IL, KS, MA, MD, MO, NE, NY, and TX and the countries of: Canada, Germany, Romania, Spain, Palestine, South Africa, France, Sweden and Singapore |
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