—#90684

Product

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K042271, K072619, K933785, K960279, K991581
Affected 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.

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-04-16
Posted by FDA: 2010-12-13
Terminated: 2012-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90684. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.