Recalls / —
—#166265
Product
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
- FDA product code
- JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K951987
- Affected lot / code info
- Lot Numbers: 16CMB0061A, 16CMB0066A
Why it was recalled
Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
Root cause (FDA determination)
Employee error
Action the firm took
The firm notified its consignees of the problem and the recall by email on 08/01/2018. The firm requested the return of the product.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- Australia, Austria, Germany, Great Britain, Poland, Spain
Timeline
- Recall initiated
- 2017-08-01
- Terminated
- 2019-02-19
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #166265. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.