NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Zimmer Inc.
- UPC
- 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.
Units Affected
10,666 all products.