FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
- Recall number
- Z-1507-2020
- Recalling firm
- Smith & Nephew, Inc.
- Product
- LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
- Status
- Terminated
- Initiated
- 2019-12-19
- Posted
- not on file
- Terminated
- 2024-09-04
- Reason
- LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
- Root cause
- Process control
- Action
- The firm initiated the recall by letter on January 6, 2020. The letter identified the problem and directed the consignee to quarantine the devices. The notice instructs to complete and return the response form and to make arrangement for the return of affected product. For any questions or concerns please contact: FieldActions@smith-nephew.com.
- Quantity
- 29 units
- Distribution
- USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).
- Lot, serial or model codes
- Lot Number 19FM12500; Product Number 71453221.
- 510(k) numbers
- K071071
- 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