FDA Medical Device Recalls (openFDA)
Zimmer Inc.: NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
- Recall number
- Z-0915-2010
- Recalling firm
- Zimmer Inc.
- Product
- NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
- Status
- Terminated
- Initiated
- 2010-01-27
- Posted
- 2010-03-02
- Terminated
- 2010-10-17
- Reason
- 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.
- Root cause
- Labeling mix-ups
- Action
- 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.
- Quantity
- 14 units
- Distribution
- US and Korea.
- Lot, serial or model codes
- lot 61369812.
- 510(k) numbers
- ["K060370"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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