Recalls / —
—#163796
Product
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 1-2 Size, 9 MM, REF 71453101designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.
- 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
- Batch Numbers: 08BM09288; 12EM05884 & 12EM07720
Why it was recalled
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Root cause (FDA determination)
Packaging process control
Action the firm took
The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Timeline
- Recall initiated
- 2018-03-30
- Terminated
- 2019-08-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #163796. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.