NexGen Complete Knee Solution Stemmed tibial broach impactor, Catalog # 00-5977-011-00, Zimmer Inc., Warsaw, IN.
This recall has been terminated (originally issued December 13, 2010).
- Company
- Zimmer Inc.
- Recall Initiated
- April 16, 2010
- Posted
- December 13, 2010
- Terminated
- September 12, 2012
- Recall Number
- Z-0609-2011
- Quantity
- 10,666 all products.
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 / Code Info
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.
Root Cause
Device Design
Action Taken
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.