Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlig
FDA device recall Z-0378-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- Headlight assembly (module) may become loose and separate from the headband assembly
- Action taken
- Integra Life Sciences notified consignees by URGENT DEVICE RECALL letter dated October 10, 2011, via FedEx, email or telephone conference calls. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to identify and return any affected product. Customers were requested to complete and return the attached Field Corrective Action Acknowledgement Form to Integra Surgical indicating receipt and review of this notification. For assistance and additional information contact your local and Integra Sales Representative or call Integra Surgical Customer Service at 1-800-431-1123.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FST
- Quantity affected
- 90 units
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico, and the countries of: Africa, Algeria, Australia, Austria, Brazil, Canada, Check Republic, China, Chile, Costa Rica, Denmark, Dominican
- Date initiated
- 2011-10-10
- Date posted
- 2012-01-11
- Date terminated
- 2012-10-01
- Location
- Plainsboro, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUTEX HEADLIGHT SYSTEMS (K864380) | Luxtec Corp. | 1986-11-19 |