Recall Z-0460-2014 — NexGen Complete Knee Solution Porous Patella Drill Guide-29mm 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 con
U.S. FDA — Device Enforcement · United States · 2013-11-19 · Class II
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Reported risk: 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.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
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