13 ft Handpiece Cable, component of the Dermatome Sets Model S and Model S6 and also as a spare part - Product Usage: ar

FDA device recall Z-2953-2020 · posted 2020-09-12 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

lntegra LifeSciences has identified through a number of complaints that the handpiece cable melts following sterilization.

Action taken

All impacted consignees will be notified by letter delivered by courier service, facsimile or email about the initial notification between August 4th and 6th, 2020. Customers are asked to remove the affected product from use and complete and return the response form to the manufacturer. After response forms are reviewed the customer will be asked to return the product and a replacement will be sent.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

GFD

Quantity affected

74 units

Distribution

Worldwide distribution - US Nationwide distribution including in the states of MN, TX, CA, UT, WV, FL, IN, GA, AZ, and the countries of Latin America ( CR, MX, TT, EC, PA ), Canada, Europe (FR, AT, BE

Date initiated

2020-08-04

Date posted

2020-09-12

Date terminated

2021-08-12

Location

Princeton, NJ