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U.S. Department of Health and Human Services

Class 2 Device Recall NT Intera

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 Class 2 Device Recall NT Interasee related information
Date Initiated by FirmAugust 20, 2004
Date PostedSeptember 29, 2004
Recall Status1 Terminated 3 on February 09, 2006
Recall NumberZ-1488-04
Recall Event ID 29966
510(K)NumberK001796 
Product Classification Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal - Product Code KRP
ProductNT Intera Magnetic Resonance Image System
Code Information Part #s 9896 030 09981, 9896 030 10251  Site #s 504531, 104343, 59488, 41391, 37996, 37979, 85119, 26269, 59435, X1281, 504409, 102353, 13606, 103166, 37929, 104392, 103149, 84418, 6947, 63046, 86293, 102978, 103904, 105315, 504866, X0038, 103582, 100745, 101946, 103333, 504412, 13056, 100786, 59428, 103818, 105314, 50430, 104808, 85139, 45016, X0716, X0942, X1272, X1086, X0214, 103324, 101420, 103579, 103847, 6808, 104467, 38652, 103347, 14117, 86335, 68196, 104032, 103417, 103243,  103207, 104102, 52408, 6841, 47029, 41346, 45065, X0164, X1082, 104912, X0083, 104054, 83325, 103911, 101477, 250156, 25958, 104193, 102547, 85172, 104897, 104070, 506190, 103946, 504608, 104340, 100462, 505007, 101595, 104095, 13932, 87527, 38966, 87604, 50336, 86085, 103291, 103592, 103098, 38257, 104532, 101162, 504897, 87018, 104336, X1693, 59637, 103143, 102933, 505021, 103631, 103552, 82678, X1635, X0162, 14065, 103530, 505568, 500034, 250498, 103099, 38438, 76359, 104138, 101561, 101560, 47043, 17394, 105271, X1215, 13057, 250475, 102569, 103770, 86313, X1179, X1523, 504632, 504527, X1412, 104942, 38317, 103101, 26119, 103509, 103544, 85433, 103547, 250122, 102896, 85158, 41342, 86012, 103907, 103909, 101408, 38420 
Recalling Firm/
Manufacturer		 Philips Medical Systems Sales & Service Region No. America
22100 Bothell Everett Hwy
Bothell WA 98021
For Additional Information ContactSarah Baxter
425-487-7665
Manufacturer Reason
for Recall		Potential for patient burn
FDA Determined
Cause 2		Other
ActionOn 8/20/04 the firm issued a letter, via certified return receipt. The letter warned of the potential for patient discomfort and burns. An addendum providing additional information regarding cable positioning was included with the letter.
Quantity in Commerce156 devices
DistributionUnits distributed to medial facilities and hospitals throughout the U.S.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KRP
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