—#86693

Product

Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52.

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 61042477.

Why it was recalled

The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.

Root cause (FDA determination)

Packaging process control

Action the firm took

Zimmer sent a recall letter, dated 11/12/09, to each initial consignee on 11/13/09. Zimmer field staff is to remove the product from affected hospitals, and to provide them with a copy of the recall letter.

Recalling firm

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

Distribution

Distribution pattern: Nationwide, Korea and Switzerland.

Timeline

Recall initiated: 2009-11-13
Posted by FDA: 2009-12-14
Terminated: 2010-10-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #86693. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.