GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA

FDA device recall Z-1900-2010 · posted 2010-06-24 · Terminated

Recall details

Recalling firm

Smith & Nephew Inc

Reason for recall

Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side

Action taken

All affected Smith & Nephew consignees (International distributors) were notified of problem and the recall via email on 04/20/2010 and an Urgent: Medical Device Recall letter, dated 4/16/2010. The letter stated the reason for the recall and distributors were requested to immediately cease distribution and use of the affected products. They were also asked to examine their stock and stock of their accounts and quarantine any affected product. The Verification Section of the letter should be completed and returned even if there is no affected stock. Anyone the product was distributed to should also be notified and also return the product. Questions should be directed to Kelly Knight at 901-399-5441.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

12 units

Distribution

International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.

Date initiated

2010-04-20

Date posted

2010-06-24

Date terminated

2011-12-07

Location

Memphis, TN