Z-0437-2013 Class II Terminated
FDA device recall Z-0437-2013 was initiated by Zimmer, Inc. on Sep 21, 2012 and is designated Class II. Reason for recall: Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating… The recall status is terminated (terminated Apr 17, 2014). Affected quantity: 123 worldwide (33 USA).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 5, 2012
- Initiation Date
- Sep 21, 2012
- Termination Date
- Apr 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123 worldwide (33 USA)
Product Description
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. 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; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Reason for Recall
Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset
Distribution Pattern
Worldwide Distribution - USA including AZ,CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA. Internationally to Thailand, Canada, Germany, France, UK, Hungary, Netherlands, Russian Fed, and Sweden,
Code Information
Catalog 00-5986-047-02, lots 62049114 and 62045235.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0437-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026