FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
- Recall number
- Z-1906-2018
- Recalling firm
- Smith & Nephew, Inc.
- Product
- smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
- Status
- Terminated
- Initiated
- 2018-03-30
- Posted
- not on file
- Terminated
- 2019-08-21
- Reason
- The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
- Root cause
- Packaging process control
- Action
- The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
- Quantity
- not on file
- Distribution
- US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
- Lot, serial or model codes
- Batch Numbers: 11DM11664 & 15BM09445
- 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