Z-0480-2014 Class II Terminated
FDA device recall Z-0480-2014 was initiated by Zimmer, Inc. on Oct 31, 2013 and is designated Class II. Reason for recall: Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold… The recall status is terminated (terminated Apr 30, 2015). Affected quantity: 128 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 18, 2013
- Initiation Date
- Oct 31, 2013
- Termination Date
- Apr 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 128 units
Product Description
NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus, or flexion deformities.
Reason for Recall
Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010 .
Distribution Pattern
Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of China, Japan and Taiwan.
Code Information
00-5980-037-02; lot 6228417
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0480-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026