Ossur Total Knee Model Number 2100, external knee prosthesis.

FDA device recall Z-1076-2007 · posted 2007-07-12 · Terminated

Recall details

Recalling firm

Ossur

Reason for recall

Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component.

Action taken

On 4/2/07 a letter was mailed to all affected customers via certified mail, return receipt requested. All mailing will be followed by telephone calls from an Ossur Customer Service Representative. Customers were notified that Ossur will replace the affected knees with units carrying a two-year warranty from the date of replacement. Ossur will undertake a sub-recall by notifying the one affected distributor by letter on 4/2/07. Ossur will follow up with this distributor by telephone and request a list of consignees that the distributor sold the product to so that Ossur can directly contact each of those consignees. Upon receipt of this list, Ossur will then communicate the recall information directly to these consignees.

Root cause

Other

Status

Terminated

Product code

ISY

Quantity affected

44

Distribution

Nationwide.

Date initiated

2007-04-02

Date posted

2007-07-12

Date terminated

2008-05-28

Location

Reykjavik, Ireland