Recall Z-0459-2014— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2013-11-19, terminated 2015-05-06. FDA's recall record names no specific 510(k) clearance for this event. Product: NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only 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: 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..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-19
- Terminated
- 2015-05-06
- Firm location
- Warsaw, IN, United States
Product description
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness Non sterile, Rx Only 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.