Zimmer Inc. Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5428-020-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5428-020-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lots 60954121, 60954122, 60954134, 60958308, 60971794, 60988246, 60993025, 61001566, 61005462, 61017822, 61023696, 61036414, 61045111, 61051494, 61065065, 61069431, 61075267, 61075288, 61085896, 61091213, 61091214, 61101487, 61106583, 61114216 and 61126557.
Products Sold
Lots 60954121, 60954122, 60954134, 60958308, 60971794, 60988246, 60993025, 61001566, 61005462, 61017822, 61023696, 61036414, 61045111, 61051494, 61065065, 61069431, 61075267, 61075288, 61085896, 61091213, 61091214, 61101487, 61106583, 61114216 and 61126557.
Zimmer Inc. is recalling Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00 due to The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026