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NexGen Complete Knee Solution recallZ-1433-2025 · Zimmer, Inc. · initiated Feb 27, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.

FDA root cause category: Labeling Change Control

What the company is doing

An URGENT MEDICAL DEVICE RECALL notification letter dated 2/27/25 was sent to customers. Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with this notice and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected]. Distributor Responsibilities: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form for each return and send to [email protected]. This form must be returned even if you do not have affected products available to return in your territory. b. For International Returns, request an IRA by emailing [email protected] c. Include

Recall details

Recall number
Z-1433-2025
Status
Open, Classified
Initiated by the company
Feb 27, 2025
Posted by the FDA
Mar 24, 2025
Recalling firm
Zimmer, Inc.
Quantity
76 units
Product code
JWH
FDA submissions
K042271
Distribution
Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME, NE, NJ, OR, SD, and TX. The countries of Canada, China, India, Netherlands, Singapore.

Product description

NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

Code information (models, lots, serial numbers)

UDI-DI: 00889024666214; Lot Numbers: 66789408, 66792792

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

33 devices cleared under K042271 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page