FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
- Recall number
- Z-0011-2007
- Recalling firm
- Smith & Nephew Inc
- Product
- Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
- Status
- Terminated
- Initiated
- 2006-08-29
- Posted
- 2006-10-03
- Terminated
- 2010-04-12
- Reason
- Tibial punches were not manufactured to specification and could break at the tip during use.
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28