Zimmer, Inc. recalls NexGen LPS Flex

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.

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

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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 CorporateQuality.PostMarket@zimmerbiomet.com. 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 zimmerbiometintlirarequests@zimmerbiomet.com c. Include

• FDA enforcement recordOfficial FDA database entry for Z-1433-2025
• FDA 510(k) clearance · K042271The device's official FDA premarket clearance record
• FDA device classification · JWHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Zimmer, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.