FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
- Recall number
- Z-1937-2014
- Recalling firm
- Zimmer, Inc.
- Product
- NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 6. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
- Status
- Terminated
- Initiated
- 2014-05-19
- Posted
- 2014-06-27
- Terminated
- 2015-10-29
- Reason
- Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
- Root cause
- Equipment maintenance
- Action
- 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.
- Quantity
- 41,180 total
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
- Lot, serial or model codes
- Size 6, includes the following Lot Numbers: 370319 37213647 37218135 37218727 37219556 37220950 61414605 61414606 61442322 61451224 61451225 61451226 61479488 61479489 61479490 61518197 61518198 61518199 61538053 61543978 61592093 61592094 61627261 61643938 61672569 61682157 61685470 61721675 61721676 61774189 61774190 61774191 61774195 61863158 61863159 61863160 61863161 61863162 61979034 61979035 62016163 62022560 62037896 62041306 62041308 62069549 62077856 62141261 62143609 62168186 62177113 62227421 62227422 62251569 62251570 62261977 62261978 62326316 62330687 62341281 62369796 62369797 62377652 62473295 62473296 62602804 62602805 62602806 62602807 62602808
- 510(k) numbers
- ["K043101"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28