—#91516

Product

GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN 38116, USA Drill guide used as manual surgical instrument during knee replacement surgeries.

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Batch # 08JM07761 and 08JM07761A.

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E. Brooks Rd, Memphis, Tennessee 38116

Distribution

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

Timeline

Recall initiated: 2010-04-20
Posted by FDA: 2010-06-24
Terminated: 2011-12-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91516. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.