FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
- Recall number
- Z-2538-2019
- Recalling firm
- Smith & Nephew, Inc.
- Product
- LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
- Status
- Completed
- Initiated
- 2018-01-15
- Posted
- not on file
- Terminated
- not on file
- Reason
- The affected products were inadvertently packaged with an incorrect screw component.
- Root cause
- Process control
- Action
- The firm sent an Urgent Medical Device Recall Notice letter dated January 15, 2018 to consignees via email. The letter identified the affected product, problem and actions to be taken. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. For questions or concerns regarding this recall contact FieldActions@smith-nephew.com.
- Quantity
- 12 units
- Distribution
- Foreign countries of; France, Germany, Netherlands, Norway, Switzerland
- Lot, serial or model codes
- 13KSL0038C
- 510(k) numbers
- ["K043440"]
- PMA numbers
- not on file
- Product code
- JWH
- 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