Smith & Nephew, Inc. LEGION PS High Flex XLPE size 5-6 9mm Articular Insert Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Brand
Smith & Nephew, Inc.
Lot Codes / Batch Numbers
Lot Number 19FM12500, Product Number 71453221.
Products Sold
Lot Number 19FM12500; Product Number 71453221.
Smith & Nephew, Inc. is recalling LEGION PS High Flex XLPE size 5-6 9mm Articular Insert due to LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, IL, LA, MI, NM, NC, OR, PA, TN, TX, PR
Page updated: Jan 10, 2026