Zimmer, NexGen Complete Knee Solution LPS Femoral… recallZ-0528-2011 · Zimmer Inc. · initiated Sep 15, 2010
Terminated All recalls posted in December 2010
Is my device affected?
- 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.
- 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.
- 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
These lots of Zimmer NexGen Complete Knee Solution LPS Femoral Component and Zimmer NexGen Complete Knee Solution LPS Flex Gender Femoral Component exhibit a nonconforming internal CAM radius. The condition is intermittent and not all devices have nonconforming geometry.
FDA root cause category: Process design
What the company is doing
The firm sent URGENT DEVICE CORRECTION AND REMOVAL notices to distributors and sales staff, Risk Managers, and implanting surgeons dated 9/15/2010. Sales staff and risk managers were instructed to return any product on hand. Surgeons were informed of the issue but there was no action to be taken by surgeons.
Recall details
- Recall number
- Z-0528-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 15, 2010
- Posted by the FDA
- Dec 2, 2010
- Recalling firm
- Zimmer Inc.
- Quantity
- 192 all sizes of 5996 products
- Product code
- JWH
- FDA submissions
- K060370, K960279
- Distribution
- US, Germany, Spain, France, UK, Italy, Sweden, South Africa, Czech Republic, Bulgaria, Poland, Romania, and Austria.
Product description
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01.
Code information (models, lots, serial numbers)
61488063
Other devices under the same FDA submission
80 devices cleared under K060370, K960279 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NexGen® Legacy® 5994-22-14Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® Legacy® 5994-32-10Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 recall0 reports
- NexGen® 5990-36-10Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER11 reports
- Gender Solutions® Female (GSF) 00-5764-015-51Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- Gender Solutions® Female (GSF) 00-5764-015-52Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- NexGen® Legacy® 5994-17-91Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- Gender Solutions® Female (GSF) 00-5764-014-52Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® 5990-36-20Zimmer, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER5 reports
- NexGen® Legacy® 5994-14-91Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® Legacy® 5994-16-91Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- NexGen® Legacy® 5994-16-92Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- Gender Solutions® Female (GSF) 00-5764-016-52Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 57178).
- Z-0529-2011 · TerminatedZimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF 00-5996-017-02.
- Z-0530-2011 · TerminatedZimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF 00-5996-016-01.
- Z-0531-2011 · TerminatedZimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02.
- Z-0532-2011 · TerminatedZimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF 00-5996-015-02.
- Z-0533-2011 · TerminatedZimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51.
- Z-0534-2011 · TerminatedZimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF 00-5764-016-52.
- Z-0535-2011 · TerminatedZimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF 00-5764-015-51.
- Z-0536-2011 · TerminatedZimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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