Z-1008-2017Class II

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

Name: Z-1008-2017 REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Creator: Smith & Nephew, Inc.
Published: 2016-11-16
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2016-11-16 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew, Inc. began a recall of REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116 on 2016-11-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1008-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-16
Posted: 2017-01-11
Terminated: 2019-08-19
Recalling firm: Smith & Nephew, Inc.
Product: REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
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 [email protected] 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 [email protected] 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
Quantity in commerce: 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.
Product codes and lots: 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, 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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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1008-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1008-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code JDI

K123598Class IISmith & Nephew, Inc. Hip System InstrumentationSmith & Nephew, Inc. / cleared 2013-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)