Events

Recall of Device Recall REFLECTION(R) DEAD BLOW MALLET

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smith & Nephew, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75751
  • Event Risk Class
    Class 2
  • Event Number
    Z-1008-2017
  • Event Initiated Date
    2016-11-16
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151142
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
  • Reason
    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.
  • Action
    Smith and Nephew sent an Urgent - Product Recall 1 st Notification dated November 16, 2016, to all affected customers. Actions for Hospital Representatives: 1. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. 2. Complete the last two columns in the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, please place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form. 3. Please contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1- 901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. 4. Return any affected product to the address listed on the Inventory Return Certification Form. Please indicate the RA number on your return shipment. Actions for Smith & Nephew Affiliates/Distributors 1.Send this letter to your customers and ask them to return the recalled product. 2. Please inspect your inventory and locate any unused devices from the above listed product and batch numbers, cease distribution and use of those products, and quarantine them immediately. 3. Complete the last two columns in the Inventory Return Certification Form above, indicating the quantities that need to be returned. If you do not have product to return, please place an x in the column No Product to Return. Include your contact information in the spaces provided at the bottom of the form. 4. Please contact Smith & Nephews Field Actions Department via email at FieldActions@smith-nephew.com or fax +1- 901-566-7975 to return the completed Inventory Return Certification Form and obtain a return authorization (RA) number if you have product to return. 5. Return any affected product

Device

Device Recall REFLECTION(R) DEAD BLOW MALLET
  • Model / Serial
    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 Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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.
  • Product Description
    REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
  • Manufacturer
    Smith & Nephew, Inc.

Manufacturer

Smith & Nephew, Inc.
  • Manufacturer Address
    Smith & Nephew, Inc., 1450 E Brooks Rd, Memphis TN 38116-1804
  • Manufacturer Parent Company (2017)
    Smith & Nephew plc
  • Source
    USFDA