—#88326

Product

NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K060370
Affected lot / code info: lot 61369812.

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US and Korea.

Timeline

Recall initiated: 2010-01-27
Posted by FDA: 2010-03-02
Terminated: 2010-10-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #88326. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.