Recalls / —
—#178954
Product
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K071071
- Affected lot / code info
- Lot Number 19FM12500; Product Number 71453221.
Why it was recalled
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).
Timeline
- Recall initiated
- 2019-12-19
- Terminated
- 2024-09-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #178954. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.