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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012
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Event Detail

Event ID 52634
Product Type Devices
Status Terminated
Recalling Firm NuVasive Inc
City San Diego
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-01-05
Initial Firm Notification of
Consignee or Public		 Letter
Distribution Pattern Nationwide Distribution-including the states of OR, MO, FL, WI, CA, and NC.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2069, JK2085, JK2102, JK2188, JK2171 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0348-2013
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2053 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0349-2013
5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2051, JK2154 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0350-2013
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2042, JK2080, JK2151 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0351-2013
5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2058, JK2054, JK2081, JK2143 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0352-2013
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2082, JK2095, JK2165 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0353-2013
5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2059, JK2084, JK2148 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0354-2013
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2057, JK2157. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0355-2013
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2083, JK2184 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0356-2013
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2052, JK2070, JK2098, JK2160, JK2093, JK2159 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0357-2013
6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2071, JK2169, JK2167. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0358-2013
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2039, JK2072, JK2168. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0359-2013
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2060, JK2046, JK2180, JK2202, JK2213, JK2230, JK2231, JK2247, JK2244 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0360-2013
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2094, JK2096 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0361-2013
7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2097, JK2190 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0362-2013
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2098, JK2187 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0363-2013
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2099, JK2186 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0364-2013
7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2056, JK2100, JK2162 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0365-2013
7.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2101, JK2163 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0366-2013
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK1949, JK2068, JK2071, JK2078, JK2079, JK2170, JK2206, JK2375, JK2387, JK2398, JK2400 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0367-2013
4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2035, JK2131, JK2349 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0368-2013
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2036, JK2132, JK2350. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0369-2013
5.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2037, JK2130, JK2037, JK2366 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0370-2013
5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2043, JK2134, JK2364, JK2367 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0371-2013
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2044, JK2144, JK2378, JK2144 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0372-2013
6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2055, JK2142, JK2172, JK2174, JK2192, JK2212, JK2173. Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0373-2013
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2045, JK2038, JK2140, JK2361, JK2362, JK2365, JK2368, JK2370, JK2369, JK2377, JK2379 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0374-2013
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: 2008400621, JK2039, JK2141, JK2191, JK2177, JK2178, JK2179, JK2181, JK2182, JK2183, JK2141, JK2181 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0375-2013
7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2040, JK2147, JK2381, JK2141 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0376-2013
7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2047, JK2152, JK2383, JK2394 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0377-2013
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI Batch: JK2041, JK2146, JK2396, JK2397 Class II The tulip portion of the screw assembly can disengage from the shank after implantation. 240 units total Z-0378-2013
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