—#85534

Product

Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3,4 or 5, sterile, Zimmer, Warsaw, IN; REF 00-5428-023-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K070214
Affected lot / code info: Lots 60964492, 60964508, 60981896, 60987854, 60987855, 60987865, 60993069, 60993070, 60993071, 60993072, 61001577, 61005472, 61023707, 61023708, 61027949, 61036430, 61051511, 61051512, 61058640, 61069446, 61075275, 61075276, 61078790, 61085908, 61091228, 61096399, 61101496, 61106596, 61114213, 61117083, 61122296 and 61136949.

Why it was recalled

The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.

Timeline

Recall initiated: 2009-10-08
Posted by FDA: 2009-11-13
Terminated: 2011-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85534. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.