Recalls / —
—#127775
Product
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 1. 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 1, includes the following Lot numbers: 37217848 61424993 61507222 61543969 61774117 62141262 62193298 62251564 62261955 62383353 62602809 62602810 62602811
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 #127775. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.