Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1902-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replacement, or total knee replacement. The constrained knee systems are designed for use in patients 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.

Product Classification:

Class II

Date Initiated: April 9, 2018

Date Posted: May 30, 2018

Recall Number: Z-1902-2018

Event ID: 79874

Reason for Recall:

A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa.

Status: Terminated

Product Quantity: 18 units

Code Information:

Lot number 16MM00441

Distribution Pattern:

US Distribution to the states of : NC, IN, CO MI, PA, NY, MA, CA, GA

Voluntary or Mandated:

Voluntary: Firm initiated