NextGen Knee Gender Solutions CR-Flex Femoral Component… recallZ-0915-2010 · Zimmer Inc. · initiated Jan 27, 2010
Terminated All recalls posted in March 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
The package should contain the left knee component but actually contains the right knee component. Delay in completing surgery may result, and a new or different implant may need to be identified.
FDA root cause category: Labeling mix-ups
What the company is doing
The firm sent an immediate notification by e-mail to all first consignees on 1/12/2010. They sent a formal recall notification on 1/27/2010. Customers should contact their Zimmer Sales representative with additional questions.
Recall details
- Recall number
- Z-0915-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 27, 2010
- Posted by the FDA
- Mar 2, 2010
- Recalling firm
- Zimmer Inc.
- Quantity
- 14 units
- Product code
- JWH
- FDA submissions
- K060370
- Distribution
- US and Korea.
Product description
NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
Code information (models, lots, serial numbers)
lot 61369812.
Other devices under the same FDA submission
17 devices cleared under K060370 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- 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
- Gender Solutions® Female (GSF) 00-5764-014-52Zimmer, 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
- Gender Solutions® Female (GSF) 00-5750-015-06Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- Gender Solutions® Female (GSF) 00-5750-015-01Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5750-015-05Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5764-013-51Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5764-014-51Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5764-016-51Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- Gender Solutions® Female (GSF) 00-5750-014-02Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- Gender Solutions® Female (GSF) 00-5750-015-02Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
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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