—#127982

Product

NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 2. 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 2, includes the following Lot numbers: 37214650 61417415 61417416 61442278 61459938 61459939 61459940 61488069 61497510 61497511 61518148 61518149 61538023 61543972 61543973 61543974 61567335 61592049 61592050 61627189 61627190 61672554 61672555 61672556 61672557 61672558 61682128 61682129 61721665 61721666 61721667 61774118 61774119 61774120 61827109 61827110 61827111 61863080 61863081 61863083 61863084 61863085 61912434 61915370 61915371 61979021 61979022 61979023 62016175 62020276 62041296 62060610 62069533 62091728 62141255 62141256 62141257 62155305 62155306 62155307 62177111 62214660 62214661 62214662 62214663 62214664 62251565 62251566 62271420 62298567 62315723 62319301 62326315 62337922 62337923 62345561 62345562 62377649 62383365 62411732 62411733 62411735 62411736 62411737 62586465 62586467 62610913 62610914 62640980 62646141 62646142

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 #127982. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.