—#163793

Product

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed 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 Number 16EM12620

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 #163793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.