Z-1902-2018 Class II Terminated
FDA device recall Z-1902-2018 was initiated by Smith & Nephew, Inc. on Apr 9, 2018 and is designated Class II. 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. The recall status is terminated (terminated Feb 22, 2019). Affected quantity: 18 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- Apr 9, 2018
- Termination Date
- Feb 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 units
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.
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.
Distribution Pattern
US Distribution to the states of : NC, IN, CO MI, PA, NY, MA, CA, GA
Code Information
Lot number 16MM00441
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1902-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026