Mark II Headlight module-black Model: 001380LX Product Usage: The fiber optic headlight system Is designed to deliver il

FDA device recall Z-0379-2012 · 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

159 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