—#127989

Product

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 8. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.

FDA product code: JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K043101
Affected lot / code info: Size 8, includes the following Lot numbers: 370321 37213648 37216196 61424999 61543980 62029931 62390069

Why it was recalled

Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.

Root cause (FDA determination)

Equipment maintenance

Action the firm took

Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.

Timeline

Recall initiated: 2014-05-19
Posted by FDA: 2014-06-27
Terminated: 2015-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127989. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.