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OVER 40,000 ZIMMER NEXGEN KNEE TIBIAL COMPONENTS RECALLED (Orthopedics This Week)
Zimmer Holdings, Inc. is recalling 41,180 stemmed tibial components of the NexGen Complete Knee Solution system.
According to an FDA Enforcement Report for the week of July 9, 2014, the company is initiating a voluntary recall of specific identified lots “due to the potential that the threads may be out of specification.” The recall is of various sizes and part of the “NexGen systems of semi-constraint, non-linked condylar knee prosthesis.”
The lots can be found here.
Recall Initiated May 19
The recall was initiated May 19, 2014 with a letter to relevant parties. The recall is considered a Class 2 recall, indicating the damaged device might cause temporary or serious medical complications. Zimmer sent out an urgent medical device recall letter to medical professionals on June 10. The components are manufactured by Zimmer Manufacturing B.V. in Puerto Rico.
In its letter to medical professionals, Zimmer reportedly said some of the tibial baseplates were made with defective threads in a hole where surgeons screw in a drop-down stem extension or stem plug. If no...
