FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
- Recall number
- Z-0227-2010
- Recalling firm
- Zimmer Inc.
- Product
- Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3, 4, or 5, sterile, Zimmer, Warsaw, IN; REF 00-5424-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
- Status
- Terminated
- Initiated
- 2009-10-08
- Posted
- 2009-11-13
- Terminated
- 2011-05-16
- Reason
- The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
- Root cause
- Other
- Action
- An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.
- Quantity
- 26,404 of all products
- Distribution
- Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.
- Lot, serial or model codes
- Lots 60975024, 60975025, 60975040, 60980765, 60980766, 60980767, 60992974, 60992975, 60992976, 61005444, 61017706, 61027890, 61036360, 61045089, 61058586, 61064815, 61075248, 61085883, 61091186, 61096369, 61106572 and 61114170.
- 510(k) numbers
- ["K070214"]
- 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