Z-1900-2010

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

Name: Z-1900-2010 GENESIS II TIBIAL DRILL GUIDE, REF 71440238, SIZE 5, QTY: (1), NON-STERILE, Smith & Nephew, Inc., Memphis, TN...
Creator: Smith & Nephew Inc
Published: 2010-04-20
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2010-04-20 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of 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... on 2010-04-20. The reason FDA records is "Markings for the drill guides are on the incorrect side: left is printed on right side and right is printed on the left side". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1900-2010
Status: Terminated
Initiated: 2010-04-20
Posted: 2010-06-24
Terminated: 2011-12-07
Recalling firm: Smith & Nephew, Inc.
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.
Product code: LXH Orthopedic Manual Surgical Instrument
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 12 units
Distribution: International Distribution Only -- Belgium, Spain, Germany, Australia, and Brazil.
Product codes and lots: Batch # 08JM07761 and 08JM07761A.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)