LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
This recall has been terminated (originally issued December 19, 2019).
- Company
- Smith & Nephew Inc
- Recall Initiated
- December 19, 2019
- Terminated
- September 4, 2024
- Recall Number
- Z-1507-2020
- Quantity
- 29 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
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 / Code Info
Lot Number 19FM12500; Product Number 71453221.
Root Cause
Process control
Action Taken
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.
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