—#99003

Product

Universal Power Supply Units, Part Number DP0007 and DP0800 , for use with the Integra Padgett Dermatomes - Model S, SB, and S6, Device Listing #E208841, 510 (k) exempt. The Integra Padgett Dermatomes are intended for use in the cutting of skin grafts for use in plastic surgery and/or burn treatment. The Model S and S6 dermatomes are intended for professional use in hospitals, and similar medical facilities, where the patient will be under the supervision of trained personnel. The Model SB dermatomes are used in skin banks for the harvesting of cadaver tissues.

FDA product code: GFD — Dermatome
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Univ ersal Power Supply, Part Number DP0007 and DP0800 , used in the Integra Padgett Dermatome, Model S, Part Numbers 3539-700; and the Integra Padgett Dermatome, Model SB, Part Number 3539-800; and the Integra Padgett Dermatome, Model S6, Part Number: 3539-900. The serial numbers for the affected units are as follows: *S-11, S-137, S-152, S-173, S-186, S-214, S-231, S-243, S-245, S-254, S36, S-233, S-234, S-235, S917P, S-237, S-238, S-239, S444, S-242, S-244, S415, S-247, S-248, S-249, S-250, S-251, S353P, S-253, S-255, S-256, S-257,S-258, S-259, S-260, S-261, S-262, S-263, S-264, S-265, S-267, S-268, S-269, S-271, S-272, S-273, S-274, S-960, S-961, S-RP-220, S-RP-140, S-RP-182, S-RP-183, S759, S767, S315P, S659, S691, S697, S703,S704, S716, S728, S739, S342P, S412, SB004, SB008, SB021, SB031, SB042, SB043, SB044, SB045, SB050, SB051, SB052, SB073, SB074, SB075, SB076, SB082, SB083, SB088, SB089, SB090, SB091, SB092, SB093, SB094, SB095, SB100, SB102, SB103, SB104, SB107, SB108, SB109, SB111, SB112, SB113, SB114, SB115, SB116, SB117, SB126,SB127, SB130, SB131, SB132, SB133, SB134, SB135, SB136, SB137, SB138, SB139, SB140, SB141, SB142,SB143, SB144, SB145, SB146, SB147, SB148, SB149, SB168, SB169, SB170, SB171, SB172, SB173, SB176,SB177, SB178, SB179, SB180, SB185, SB190, SB192, SB193, SB194, SB195, SB196, SB197, SB198, SB199, SB200, SB204, SB206, SB208, SB210, SB211, SB216, SB221, SB222, SB229, SB231, SB232, SB233, SB237, SB241, SB242, SB243, SB244, SB254, SB256, SB257, SB258, SB259, SB260, SB261, SB262, SB263, SB264, SB265, SB266, SB267, SB268, SB269, SB270, SB271, SB272, SB273, SB274, SB275, SB276, SB291, SB304P, SB327, SB337, SB44, S857, S288, S436, S3856, S3886, S626, SRP220, S714, S715P, SB153, SB154, SB155, SB156, S612, S619, S620, S625, S684, N/A, N/A, SRP223(a), S496, S497, S509, S683, N/A, N/A, S341, S595, S610, S613, S618, S635, S637, S638, S680, S862, S865, S780, S764, S770, S773, S774, S916, S511P, S707,S782, S811, S358, S359, S3866, S456, S428, S520, S430, S431, S432, S529, S455, N/A, N/A, S506, S508, S686, S849, S927, SB249, SB250, SB251, SB252, SB253, SB255, S438, S439, S440, S481, S482, S484, S485, S486, S487, S542P, S596, S694, S696, S634, S495(a), S699, S718, S744, S745, S747, S519, S-538, S818, 5871, S291,S292, SRP228, S644, S645, S650, SB175, S391, S463, S453, S310, S348, S355, S368, S369, S370, S371, S372, S373, S374, S381, S382, S383, S384, S530, S654, SB006, SB038, SB105, SB125, SB128, SB129, SB150, SB151,SB152, SB157, SB158, SB159, SB160, SB161, SB162, SB163, SB164, SB165, SB166, SB167, SB174, SB181,SB182, SB183, SB184, SB186, SB187, SB188, SB189, SB191, SB201, SB202, SB203, SB205, SB207, SB223,SB224, SB227, SB228, SB278, SB279, SB280, SB281, SB286, SB297, SB331, SB332, SB88, SB039, S469, SB005, SB010, S679, S604, S760, S776, S594, S771, S473, S772, S785, S449, S435, S551, S817, S814, S779 S710, S719, S724, S727, S419, S709, 1/1/1989, N/A, N/A, SB123, S611, 1-582, S523, S524, S526, S527, S531, S532, S533, S582, S614, S295, S296, S362, S363, S577, S677, S387, S777, S778, S3936, S416, S417, S418, S390, S521, S539, S548, S583, S655, S669, S673, S495(b), S733, S546, S477, S514, S516, S517, S333, S681, S781,S839, S706, S424, S446, S660, S726, S361, S545, S682, S700, S717, SRP185, S330, S437, N/A, N/A, N/A, N/A, S276, S277, S278, S279, S280, S281, S282, S283, S284, S286, S287, S289, S290, S297, S298, S299, S305, S307,S308, S344, S345, S346, S347, S395, S396, S397, S398, S399, S400, S401, S402, S403, S404, S405, S406, S407,S408, S409, S410, S411, S420, S421, S422, SB016, SB017, SB018, SB023, SB024, SB025, SB026, SB027, SB028, SB032, SB033, SB034, SB035, SB036, SB037, SB040, SB041, SB046, SB047, SB049, SB053, SB054, SB055,SB056, SB057, SB058, SB059, SB060, SB061, SB062, SB063, SB064, SB066, SB067, SB068, SB069, SB071,SB072, SB077, SB078, SB079, SB080, SB081, SB084, SB085, SB086, SB087, SB106LC, SB118, SB119, SB120, SB121, SB122, SRP172, SRP173, SB289, SB290, SB324, SB328, SB329, SB330, SB2PC, SB007P, S312P, S736, S749, S752, S597, S598, S599, S4206, S816, S350, S351, S356, S357, S3816, S3876, S665, S675, S851, SRP229,S551, S605, S929, S608, S609, S648, S688, N/A, N/A, N/A, N/A, N/A, N/A, S450, S758, S906, S554, S678, S559, S713, S603, N/A, N/A, N/A, N/A, S513, S788, S789, S306, S4006P, N/A, N/A, SRP211, S322, S323, S457, S458, S319P, S300, S850, S689, S560, S561, S563, S568, S570, S572, S343, S429, S580, S337, S3966, S4016, S4056P,S666PZ, SB282, SB283, SB284, SB285, SB287, SB288, S507, SB065, SB070, SB097, SB098, S366, S367, SB013,SB015, S565, SRP222, S4196, S812, 5587, 5588, 5589, S587, S589, N/A, N/A, S914, S492, S685, S493, S364,S365P, SB012, SB014, SB225, SB226, SB230, SB240, SB277, S502, N/A, N/A, S540, S541, S692, S693, S695, S555, S556, S649, S768, S783, SRP184, SRP186, S483, S720, S543, S544, S336, S360, S905, S314P, S317P,S3836, S3846P, S392, S393, S394P, S4036P, S413, S414, S479, S490, S491, S501, S510, S549, S746P, S748P,SB099, SB101, SB234P, SB235P, SB236, SB245P, SB246, SB247, SB248, SRP243, S459, S3976, S601, S602,S454, S331, SRP242, S926, S925, S633, S629, S550, S488, S489, N/A, N/A, S896, S895, S890, S302, S301, N/A, N/A, SRP231, S293, S923, S349, S750, S442, S441, SRP244, S607, S443, S586, 5586, S309, S584, S576, S471, S910, S687, S536, SRP233, SRP232, S3826, S385, S294P, S784, S753, S751, S722, S721, S711, S708, S705, S698,S579, S578, S575, S574, S573, S567, S558, S557, S329, S328, S327, S326, S325, S324, S389, S690, S663, S661, S335, S334, S332, SB239P, SB238, S730P, S729P, S725, S285, SB124, SB110, S647, S464, S448, S434, S909,S853, S847, S731, S475, S474, S472, S4136, SRP227, SRP221, S339, S466, S908, SRP188, SRP187, SB326, SB325, SB323, SB296, SB295, SB294P, SB293, SB292, SB220, SB219, SB218, SB217, SB215, SB214, SB213, SB212, SB209, S476, S468, S467, S4026P, S3916P, S3906L, S503, S754, S848, S641, S636, SRP201, SRP200, SRP199, SRP198, SRP197, SRP196, SRP195, SRP194, S623, S621, SRP230, S674, S667, S547, S919, S918, S632, S631, S630, S628, S737, S622, S352, S3986, S3926, SRP223(c), N/A, N/A, S735, S593, S592, S591, S590, S581, S500, S499P, S740, S852, S734, S732, and S892. *All Dermatome Power Supply units distributed from 3/2/2005 through 4/19/2010 are subject to recall/replacement. According to the firm, cerain of the suspect units distributed had no identifiable serial numbers but recall letters were sent to the customers of these units. The firm chose to identify these units as: N/A for the sake of counting the serial numbers of the affected product.

Why it was recalled

Dermatome power supply units distributed by the recalling firm may not meet the required medical device electrical safety regulations which can result in an increased potential for electric shock to the device user and/or patient.

Root cause (FDA determination)

Other

Action the firm took

Integra LifeSciences Corp. initiated their recall by contacting their Sales Representatives via telephone conference calls on 3/10/2011. Separate written recall communications, in the form of an 'URGENT PRODUCT RECALL NOTIFICATION' were provided via E-mail and FedEx to the firm's Sales Representatives on 3/11/2011; and to their hospital and distributor customers on 3/11/2011; 3/14/2011; and on 4/12/2011. The recall notification addressed to the non-Integra Sales Rep customers informs the customers of the problem with the power supply units (that they may not meet the required medical device electrical safety standards which may result in an increased potential for electrical shock). The notification goes on to ask that the customers examine their inventories and determine if they have any affected product on-hand; if so, the customers are instructed to discontinue use of the power supply unit and return the unit(s) to Integra LifeSciences Corporation immediately for reworking. The letter also provides photographs of the affected units which the customer can use to locate and verify the serial number(s) of the device (if applicable). In addition, the notification is accompanied by a 'RECALL ACKNOWLEDGMENT AND RETURN FORM' which the customer is asked to sign and complete in order to document receipt of the recall notification and whether or not the customer has any of the recalled power supply units available for return. The notification letter provided to the Integra Sales Representatives describes the device models affected; the reason for the recall; and asks that the Reps. examine their inventories for the presence of any of the affected power supply units. If found, the Reps are instructed not to use, or to further distribute any of the affected units in their possession, but to immediately make arrangements to return the unit(s) to Integra for rework. The notification supplied to the Sales Reps provides them with a synopsis of the firm's field action

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: Worldwide Distribution - USA including FL, CO, IL, AR, MD, IN, CA, MT, AZ, NY, LA, TX, MA, MO, CT, MI, NE, OH, NC, WV, VA, PA, NJ, TN, UT, MN, OK, WI, GA, AL, WA, KS, OR, AK, DC, SC, NE, MS, RI, NV, IA, and ND and the country of Canada

Timeline

Recall initiated: 2011-03-11
Posted by FDA: 2011-05-20
Terminated: 2012-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99003. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.