Z-0463-2014 Class II Terminated
FDA device recall Z-0463-2014 was initiated by Zimmer, Inc. on Nov 19, 2013 and is designated Class II. Reason for recall: This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the… The recall status is terminated (terminated May 6, 2015). Affected quantity: 439 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 18, 2013
- Initiation Date
- Nov 19, 2013
- Termination Date
- May 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 439 units
Product Description
NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
Reason for Recall
This is an expansion of the June 2013 recall of NexGen Micro components. Five (5) additional instruments have been identified that are associated only with the NexGen Micro components. There is the potential for these devices to be inadvertently utilized during surgery, resulting in a delay. The associated implants would not be available due to the previous recall.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.
Code Information
Part Number 00-5971-041-09
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0463-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026