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Recall Observatory FDA recall evidence

Device product

smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent. The Revision Knee Components are for single use only and are intended for implantation with bone cement.

Z-0092-2018

September 14, 2017

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 78140
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-0092-2018

Official wording

Reason: The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.

Code information: Lot Number 14GSM0440A

Distribution pattern: US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.