Zimmer Inc.: NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.

Recall number

Z-0609-2011

Recalling firm

Zimmer Inc.

Product

NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.

Status

Terminated

Initiated

2010-04-16

Posted

2010-12-13

Terminated

2012-09-12

Reason

The impactor may disassemble or detach during use. The detached piece may not be observed intraoperatively and may be left in the surgical site. Complications may include pain, infection, and prolongation in surgery. These complications may also require revision surgery.

Root cause

Device Design

Action

Zimmer issued "Urgent Medical Device Safety Alert" letters dated April 16, 2010 to Risk Managers, user facilities, Health Care Professionals and Zimmer Sales force. The users were informed to inspect the device for loosening. The alert also informed users to inspect the device after each use to verify that the device was intact. Customers were instructed to complete and return a User Facility Documentation Form. Zimmer will repair and replace all affected devices. Customers can contact ZImmer, Inc. at 800 613-6131 concerning this recall.

Quantity

10,666 all products.

Distribution

Worldwide Distribution: Throughout US including Puerto Rico, and the countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, El Salvador, France, Germany, Guatemala, Hong Kong, India, Italy, Japan, Korea, Mexico, Netherlands, Nicaragua, Panama, Peru, Portugal, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.

Lot, serial or model codes

61650800, 64173900, 64314000, 64592700, 64899900, 65307200, 66384700, 67271500, 68001000, 68507500, 70066700, 72635200, 73040600, 74330100, 78288600, 78775900, 79027000, 79301900, 79414800, 79911900, 50006600, 50243100, 50435900, 51091100, 05478400, 52676400, 53616000, 53780600, 54122000, 54289900, 54601600, 55023000, 55023000, 55307800, 56221200, 56599400, 56760200, 56795200, 56934500, 56974400, 57038500, 57111600, 57128100, 57241400, 57440800, 57329200, 57510900, 57543000, 57575000, 57645600, 57854100, 57918600, 57808100, 58005700, 58318100, 58318200, 58575700, 58812400, 58784400, 59456600, 59183600, 59671000, 59660300, 59786900, 60481100, 60844300, 60903700, 60939100, 61813100, 62260000, 05631100, 62994200, 64835300, 65403600, 65861500, 66614100, 66883200, 67441900, 67599300, 68466000, 68764200, 69175100, 69286900, 70153900, 70294600, 70658600, 71027500, 71280200, 71572500, 71866600, 72502300, 72829600, 73433500, 74078000, 74644700, 74750900, 75331100, 75504400, 76422600, 79626500, 41996400, 52288600, 53220100, 54000500, 60007281, 60025415, 60029968, 60034339, 60056415, 60066606, 60064664, 60077494, 60079251, 60091628, 60092158, 60102687, 60105706, 60115562, 60117109, 60120485,  60124571, 60137142, 60149310, 60160018, 60174138, 60194573, 60195084, 60209845, 60219302, 60224592, 60226046, 60225877, 60240482, 60271491, 60278677, 60280712, 60302621, 60314459, 60328822, 60341569, 60359101, 60362634, 60366062, 60378347,  60380488, 60398085, 60401003, 60425875, 60439542, 60451190, 60523326, 60547208, 60565239, 60568430, 60582612, 60587278, 60603208, 60652168, 60685947, 60723702, and 60781789.

510(k) numbers

["K042271","K072619","K933785","K960279","K991581"]

PMA numbers

not on file

Product code

LXH

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

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

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