D3000 Advantage Drive System, 115v Product Usage: The Advantage Drive Systems function as a powered instrument system co
FDA device recall Z-0916-2013 · posted 2013-03-06 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- 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 taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GEY
- Quantity affected
- 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
- Date initiated
- 2013-01-24
- Date posted
- 2013-03-06
- Date terminated
- 2013-07-05
- Location
- Largo, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCED TURBO DRIVE SYSTEM (K050519) | Linvatec Corp. | 2005-05-17 |