Z-0011-2007

Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

Name: Z-0011-2007 Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Creator: Smith & Nephew Inc
Published: 2006-08-29
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2006-08-29 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105 on 2006-08-29. The reason FDA records is "Tibial punches were not manufactured to specification and could break at the tip during use". 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-0011-2007
Status: Terminated
Initiated: 2006-08-29
Posted: 2006-10-03
Terminated: 2010-04-12
Recalling firm: Smith & Nephew, Inc.
Product: Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Tibial punches were not manufactured to specification and could break at the tip during use.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email and telephone follow-up) on 08/29/2006 to request the return of any in stock product.
Quantity in commerce: 62 units
Distribution: Worldwide distribution ----- including USA and countries of Austria, Australia, Belgium, Canada, China, Dubai, France, Germany, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, South Korea, Spain, Turkey, United Kingdom, and Venezuela.
Product codes and lots: Catalog Number 71927102 (Size 1-2) Lot Numbers 06AM00936, 05KM07017, 04KM18886, 04JM05040, 03FM11332, 03FM11334, 03DM01797, 02FM07372, 02CM04108, 01LM08844, 01AM16024, 00306631 Catalog Number 71927103 (Size 3-4) Lot Numbers: 06AM00937, 04LM11514, 04KM18887, 04KM12225, 04FM08554, 03FM11350, 03FM11352, 03DM01798, 02FM07387, 02CM04110, 01LM08847, 00306632 Catalog Number 71927104 (Size 5-6) Lot Numbers: 04KM15385, 04LM09224, 03FM11353, 03DM01800, 02CM04114, 01LM08850, 00306635 Catalog Number 71927105 (Size 7-8) Lot Numbers: 06AM00940, 05KM07018, 04KM18889, 04LM09225, 04FM08555, 03FM11356, 03FM11355, 03DM01803, 02CM04121, 02CM04118, 01LM08854, 01LM08852, 01HM12256, 01BM14137, 00306638

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)