FDAClass IIJanuary 18, 2017

Reflection(r) Dead Blow Mallet recall

REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116

Why was Reflection(r) Dead Blow Mallet recalled?

The firm received complaints of cracks in the weld on the head of the mallet. In the reported cases, some of the lead beads and particles escaped from the mallet into the surgical wound.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

606861, 606862, 606863, 606864, 701432, 701433, 808421, 808422, 1200840, 50903653, 60708545, 60806634, 61005467, 70704991, 70907344, 71002434, 71106654, 71106655, 80603593, 80603594, 80609278, 80610026, 80807064, 81007463, 81108699, 81202445, 90309401, 90309402, 90309937, 90309941, 90309943, 7136210699, 00701432A, 01BM13815, 01BM13816, 01GM03498, 01GM03503, 01GM03504, 01GM03506, 01JM01382, 02DM06721, 02DM06722, 02EM06595, 02FM01963, 2LM00998, 02LM01099, 02LM01100, 02MM02211, 02MM02211A, 03CM01191, 03EM04694, 03HM11994, 03KM13414, 04AM06979, 04BM09860, 04DM13907, 04DM17920, 04DM17921, 04EM07129, 04EM07132, 04GM03326, 04GM03327, 04GM03328, 04GM03329, 04GM03330, 04KM01861, 04KM13683, 04KM13684, 04MM02700, 04MM02701, 05AM14642, 05AM14643, 05AM14644, 05AM14645, 05AM14646, 05AM14646A, 05EM08660, 05EM08661, 05FM07198, 05FM07199, 05GM00620, 05GM00621,05GM00622, 05GM01203, 05GM01204, 05GM01205, 05GM02670, 05GM02671, 05GM05689, 05GM05690, 05GM05692, 05GM08285, 05GM08286, 05GM08287, 05HM03895, 05HM03896, 05HM07787, 05HM07788, 05HM07789, 05HM07790, 05HM07791, 05HM08138, 05HM08139, 05HM08140, 05HM12179, 05HM12180, 05JM02349, 05JM02350, 05LM11363, 05LM11364, 05LM11365, 05MM07114, 05MM07115, 05MM07116, 06AM12304, 05MM07114, 06DM06240, 06FM08915, 07AM04686, 07EM23206, 05MM07115, 06DM08506, 06GM03246, 07AM04687, 07EM23207, 05MM07116, 06DM08507, 06GM03247, 07AM04688, 07EM23207A, 06AM12304, 06DM08508, 06GM04389, 07AM04689, 07EM23208, 06AM12306, 06DM08510, 06GM04390, 07BM11025, 07FM13912, 06AM12307, 06DM08511, 06HM04336, 07BM11027, 07FM22176, 06BM06458, 06DM08513, 06HM04337, 07BM11028, 07FM22177, 06BM06459, 06DM14258, 06HM13309, 07CM20766, 07FM22177R, 06BM06460, 06EM07997, 06HM13310, 07CM20767, 07FM22179, 06DM03707, 06EM07998, 06HM13311, 07CM20769, 07FM22180, 06DM03709, 06EM07999, 06HM13312, 07CM20770, 07FM22180R, 06DM03710, 06EM08000, 06KM05142, 07CM20772, 07FM22181, 06DM04641, 06EM08001, 06KM05143, 07CM20773, 07FM22181R, 06DM04642, 06EM08913, 06KM05144, 07DM20507, 07GM15214 06DM04643, 06EM08914, 06KM09904, 07DM20511, 07JM08242, 06DM04644, 06EM08915, 06KM09905, 07DM20512, 07JM08244, 06DM04645, 06EM08916, 06LM07300, 07DM20513, 07JM08246, 06DM04646, 06EM08917, 06LM07302, 07DM20517, 07JM08248, 06DM06236, 06EM15667, 06MM06711, 07EM17133, 07JM08253, 06DM06237, 06EM15668, 06MM06712, 07EM17134, 07JM08254, 06DM06238, 06EM18051, 07AM04684, 07EM17135, 07JM08254R, 06DM06239, 06FM05947, 07AM04685, 07EM17139, 07JM08256, 07KM02873, 08GM15339, 09EM01236, 10MM09446, 11MM06903, 07KM02875, 08GM15340, 09EM01237, 10MM09448, 12BM07223, 07KM02876, 08GM15341, 09EM01238, 10MM09450, 12BM10723, 07KM02877, 08GM15342, 09EM01239, 11AM08358, 12BM10724, 07KM17062, 08HC08114, 09EYW0009, 11AM08358A, 12BM17244, 07KM17063, 08HM08096, 09EYW0009A, 11AM08359, 12BM17245, 07KM23733, 08HM08100, 09EYW0009B, 11AM08359A, 12BM18966, 07KM23734, 08HM08101, 09EYW0009C, 11AM08360, 12CM17458, 07KM23735, 08HM08104, 09EYW0009D, 11AM08361, 12DM05835, 07LM10125, 08HM08105, 09EYW0009E, 11AM08364, 12DM05835A, 07LM10126, 08HM08106, 09EYW0010, 11AM10562, 12DM05836, 07LM10127, 08HM08107, 09EYW0010A, 11AM10564, 12DM05836A, 07LM10128, 08HM08108, 09EYW0010B, 11AM10566, 12DM10416, 07LM10129, 08HM08109, 07LM13415, 08HM08110, 07LM13416, 08HM08111, 07LM13417, 08HM08113, 07LM13418, 08HM08114, 07LM13419, 08HM08115, 07LM13420, 08HM08116, 07MM13910, 08MM15605, 07MM13911, 08MM15605A, 07MM13911R, 08MM15606, 07MM13912 , 08MM15608, 07MM13912R, 08MM15609, 07MM13914, 08MM15611, 07MM13915, 09AM19274, 07MM13917, 09AM19276, 07MM13917R, 09BM09445, 08AM04897, 09BM09447, 08EM13465, 09BM09449, 08EM19975, 09BM09450, 08FM09824, 09BM15217, 08FM09826, 09BM15219, 08FM09827, 09BM15220, 08FM09829, 09BMI5217, 08FM11005, 09BMI5219, 08FM11006, 09BMI5220, 08FM16340, 09BMO9445, 08FM16341, 09BMO9450, 08FM16342, 09CM18713, 08FM16343, 09CM18715, 08FM16344, 09CM18717, 08FM16345, 09CMI8715, 08GM15336, 09DM13396, 08GM15337, 09DM13399, 08GM15338, 09DM13400, 12KM16514, 12KM16515, 12KM17287, 12LM02029, 12LM02109, 12LM07522, 13BM15733, 13CM12241, 13CM12244, 13DM05887, 13DM05888, 13DM09094, 13DM11253, 13DM19796, 13DM20982, 13DM20982A, 13EM09454, 13EM09455, 13FM02852, 13FM18101, 13FM18102, 13FM18102A, 13GM09614, 13GM09615, 13GM10866, 13GM20305, 13HM01391,13HM04334, 13HM20062, 13JM09524, 08HM08109, 08HM08110, 08HM08111, 08HM08113, 08HM08114, 08HM08115, 08HM08116, 08MM15605, 08MM15605A, 08MM15606, 08MM15608, 08MM15609, 08MM15611, 09AM19274, 09AM19276, 09BM09445, 09BM09447, 09BM09449, 09BM09450, 09BM15217, 09BM15219, 09BM15220, 09BMI5217, 09BMI5219, 09BMI5220, 09BMO9445, 09BMO9450, 09CM18713, 09CM18715, 09CM18717, 09CMI8715, 09DM13396, 09DM13399, 09DM13400, 14BM01667, 14BM01668, 14BM01669, 14BM01670, 14BM01671, 14BM01672, 14BM01673, 14BM04157, 14BM04158, 14BM04159, 14BM04160, 14BM04160R, 14CM16664, 14CM17194, 14DM00236, 14DM08760, 14DM08761, 14DM13479, 14EM05451, 14EM06451, 14EM11507,14EM18730, 14EM22863, 14EM22864, 14FM01204, 14FM01205, 14FM17260, 14GM01262, 14GM03572, 14GM10619, 09EYW0010C, 09EYW0011, 09EYW0011A, 09EYW0011B, 09EYW0011C, 09EYW0011D, 09EYW0011E, 09EYW0011F, 09EYW0012, 09EYW0012A, 09EYW0012B, 09EYW0012C, 09EYW0012D, 09EYW0013, 09EYW0013A, 09EYW0013B, 09EYW0013C, 09MM09122, 10GM03167, 10GM05180, 10HM00478, 10HM00480, 10HM01652, 10HM08505, 10HM08505R, 10HM11149, 10HM11149R, 10HM16824, 10HM16824R, 10HM16824S, 10LM01590, 10MM09443, 10MM09444, 10MM09445, 11AM10566A, 11AM11219, 11AM11221, 11CM04420, 11CM06074, 11CM15011, 11DM02748, 11EM14498, 11EM16916, 11FM04754, 11FM04759, 11FM04761, 11FM04767, 11GM05674, 11GM05675, 11GM05676, 11GM10213, 11HM09823, 11HM11556, 11HM15618, 11HM15619, 11HM15620, 11HM15620A, 11JM06646, 11KM03092, 11KM03094, 11KM03095, 11KM03096, 11KM03097, 11MM06746, 11MM06746A, 11MM06894, 11MM06898, 11MM06901, 12DM10417, 12DM10420, 12DM10420A, 12EM00715, 12EM00717, 12EM00717A, 12EM04424, 12EM04425, 12EM07109, 12EM07110, 12EM07111, 12GM06808, 12GM11585, 12HM06211, 12HM06213, 12HM06213A, 12HM06215, 12HM06216, 12HM10408, 12HM11856, 12HM11857, 12HM11857R, 12JM00568, 12JM00569, 12JM00569A, 12JM00570, 12JM00571, 12JM00572, 12JM00573, 12JM04979, 12JM04981, 12JM04983, 12KM16512, 12KM16513, 14MM09041, 14MM13547, 15AM02615, 15AM08843, 15CM15790, 15DM07667, 15DM08587, 15DM10613, 15DM12768, 15DM13536, 15DM13537, 15DM20374, 15EM03979, 15FM16705, 15FM16706, 15JM03486, 15JM03487, 15JM03488, 15JM05522, 15JM05523, 15JM05524, 15JM05525, 15JM05526, 15JM14855, 15JM14999, 15JM15003, 15JM15004, 15JM15005, 15JM15006, 15JM15008, 16BM15809, 16BM15810, 16BM15811, 16BM20892, 16CM00513, 16CM01482, 16CM01483, 16CM08603, 16EM01010, 16EM01012, 16EM13209, 16EM13210, 16EM13211, 16EM18044, 16EM18046, 16FM01913, 16FM03541, 16FM11256, 16FM11257, 16FM11258, 16FM15697, 16FM15698, 16FM15699, 16FM15700, 16GM14186, 16GM14187, 16GM18830, 61005467A, 70907344A, 71106654A, 13JM09525, 14GM12600, 15JM15788, 71106655A, 13JM09526, 14GM14974, 15JM15789, 80603594A, 13JM10159, 14GM18996, 15JM15790, 80609278A, 13KM08048, 14HM04314, 15JM15791, 13KM08052, 14HM18762, 15LM09208, 13KM10776, 14JM06466, 15LM10375, 13KM22390, 14JM09489, 15LM10376, 13KM22391, 14JM10770, 15LM11432, 13LM07967, 14LM01406, 15LM11433, 13LM20117, 14LM01406R, 15LM19635, 13MM07087, 14LM09219, 15MM11292, 13MM07510, 14LM09227, 15MM11295, 13MM16218, 14LM09235, 15MM11296, 14AM09464, 14LM09245, 16AM00592, 14BM00550, 14LM09247, 16AM01881, 14BM00551, 14LM10680, 16BM15807, 14BM01666, 14MM03602, 16BM15808

Product
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Recalling firm
Smith & Nephew, Inc.
Quantity
4444 units
Distribution
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, China, Colombia, Costa Rica, Dubai, Denmark, Germany, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Mexico, Malaysia, Netherlands, Norway, Poland, Portugal, Puerto Rico, South Africa, Sweden, Singapore, Switzerland, Thailand, Turkey and Venezuela.
Recall date
January 18, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls