Recall Z-0480-2014— Zimmer, Inc.

Name: FDA recall Z-0480-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-31

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-10-31, terminated 2015-04-30. It names one FDA 510(k) clearance: K933785. Product: NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. 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.. Reason: Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-31
Terminated: 2015-04-30
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K933785 — NEXT GENERATION KNEE SYSTEMZimmer, Inc.·cleared 1995-01-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NexGen¿ Complete Knee Solutions Stemmed Tibial Component Precoat NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. 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.

Reason for recall

Two complaints were received in which it was reported that the stem would not lock into the tibia. Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010.

Data sourced from openFDA. This site is unofficial and independent of the FDA.