FDA Medical Device Recalls (openFDA)
Smith & Nephew Inc: JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422232, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116
- Recall number
- Z-0930-2010
- Recalling firm
- Smith & Nephew Inc
- Product
- JOURNEY " UNI TIBIAL BASEPLATE, RIGHT MEDIAL/LEFT LATERAL, A/P 42 MM, M/L 25 MM, REF 71422232, FOR CEMENTED USE ONLY, QTY: (1), STERILE R, SMITH & NEPHEW, INC. MEMPHIS, TN 38116
- Status
- Terminated
- Initiated
- 2009-01-23
- Posted
- 2010-03-03
- Terminated
- 2011-03-25
- Reason
- The firm has received complaints of the base plates breaking in situ. If a breakage occurs, the broken baseplate must be revised and/or changed. If left unrevised a broken base could lead to instability and premature wear of the construct.
- Root cause
- Device Design
- Action
- All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 12/23/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. For questions, please contact the firm, Leah Easley at 901-399-6137.
- Quantity
- 628 units
- Distribution
- US and Argentina, Switzerland, Australia, Canada, Belgium, Italy, Spain, Thailand, Austria; PROC, Finland, Germany, Malaysia, Portugal, Netherlands, Singapore, and England
- Lot, serial or model codes
- All Lot Numbers
- 510(k) numbers
- ["K052265"]
- PMA numbers
- not on file
- Product code
- HSX
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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