Zimmer, Inc.: 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.

Recall number

Z-0480-2014

Recalling firm

Zimmer, Inc.

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.

Status

Terminated

Initiated

2013-10-31

Posted

2013-12-11

Terminated

2015-04-30

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.

Root cause

Device Design

Action

All distributors will be notified via electronic mail. Hospital risk managers and distributors with affected inventory will also be notified via courier. Surgeons that have implanted this manufacturing lot will be identified and notified by the distributor. Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory, as well as identifying and notifying surgeons that have implanted this manufacturing lot. Distributors will return on-hand affected products to Zimmer and ensure all of their products are accounted for using Attachment 1 provided in the letter. Distributors are to complete and return Attachment 2 indicating which surgeons have implanted the product and to which they have provided notice to. Hospitals that received direct shipments from Zimmer will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product and returning it to their Zimmer sales representative. Communications outside of the United States will occur approximately two weeks after the United States communications. Zimmer will conduct effectiveness checks in the following way: Distributors/Hospitals o 100% of the FedEx notifications will be accounted for o An inventory certification form will need to be returned from each distributor that certifies that all available affected product from their territory has been returned. o Additional notifications via email and FedEx will be sent to those who have not completed the required certification form o Accounts will be deemed unresponsive after 3 attempts. Further questions please call 800-613-6131.

Quantity

128 units

Distribution

Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of China, Japan and Taiwan.

Lot, serial or model codes

00-5980-037-02; lot 6228417

510(k) numbers

["K933785"]

PMA numbers

not on file

Product code

JWH

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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