Recall Z-0378-2012
Integra LifeSciences Corp. · initiated October 10, 2011
Product
Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgical site illumination.
Codes / lots: All serial numbers
Reason for recall
Headlight assembly (module) may become loose and separate from the headband assembly
FDA-determined cause: Device Design
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.
Details
- Recall number
- Z-0378-2012
- Initiated
- October 10, 2011
- Posted by FDA
- January 11, 2012
- Terminated
- October 1, 2012
- Product code
- FST – Light, Surgical, Fiberoptic
- Quantity
- 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 Republic, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece Hungary, Guatemala, India, Ireland, Israel, Italy, Iraq, Japan, Jordan, Kenya, Kuwait, Lebanon, Lithuania, Macedonia, Mexico…
- Recalling firm
- Integra LifeSciences Corp., Plainsboro, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0373-2012 | Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage:…Headlight assembly (module) may become loose and separate from the headband assembly | 10/10/2011Terminated |
| Z-0374-2012 | Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF…Headlight assembly (module) may become loose and separate from the headband assembly | 10/10/2011Terminated |
| Z-0375-2012 | Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber…Headlight assembly (module) may become loose and separate from the headband assembly | 10/10/2011Terminated |
| Z-0376-2012 | Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage:…Headlight assembly (module) may become loose and separate from the headband assembly | 10/10/2011Terminated |
| Z-0377-2012 | Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber…Headlight assembly (module) may become loose and separate from the headband assembly | 10/10/2011Terminated |
| Z-0379-2012 | Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight…Headlight assembly (module) may become loose and separate from the headband assembly | 10/10/2011Terminated |
| Z-0380-2012 | Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage: The…Headlight assembly (module) may become loose and separate from the headband assembly | 10/10/2011Terminated |
| Z-0381-2012 | UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight…Headlight assembly (module) may become loose and separate from the headband assembly | 10/10/2011Terminated |