Microsoft Word - R Field Safety Notice_eng

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1 Smith & Nephew Inc T Brooks Road Memphis, TN [Recipients Address] August 29, 2016 URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action / Recall Reference: R Concerned Devices: TANDEM BIPOLAR HIP SYSTEM Product No Description COCR 40OD 22ID COCR 41OD 22ID COCR 42OD 22ID COCR 43OD 28ID COCR 44OD 28ID COCR 45OD 28ID COCR 46OD 28ID COCR 47OD 28ID COCR 48OD 28ID COCR 49OD 28ID COCR 50OD 28ID COCR 51OD 28ID 59OD 28ID TNDM SHL/XLPE LNR 39OD26ID LNR 40OD 26ID LNR 41OD 26ID LNR 42OD 26ID LNR 43OD 26ID LNR 57OD 26ID Product No Description COCR 52OD 28ID COCR 53OD 28ID COCR 54OD 28ID COCR 55OD 28ID COCR 57OD 28ID 38OD 22ID 39OD 22ID 40OD 22ID 41OD 22ID 42OD 22ID 43OD 28ID 44OD 28ID 44OD 26ID 45OD 26ID 46OD 26ID 47OD 26ID 48OD 26ID 49OD 26ID TNDM BPLR COCR SAMP Product No Description 45OD 28ID 46OD 28ID 47OD 28ID 48OD 28ID 49OD 28ID 50OD 28ID 51OD 28ID 52OD 28ID 53OD 28ID 54OD 28ID 55OD 28ID 57OD 28ID 50OD 26ID 51OD 26ID 52OD 26ID 53OD 26ID 54OD 26ID 55OD 26ID Trademark of Smith & Nephew 1 / 8

2 Dear Dr. This letter is to inform you that Smith & Nephew, Inc. has initiated a voluntary field safety corrective action for several lots from the HIP SYSTEM due to a manufacturing error which affected a number of devices in the batches listed below. The affected devices were manufactured with an out of specification retainer groove location. The out of specification condition could potentially result in one of three functional failures: the device will not assemble, the head is too tight or in rare occasions, the device may appear to assemble but later disassociate post operatively. 본서한은아래에리스트된배치의제품에영향을미치는제조문제로인하여 HIP SYSTEM 의 일부 lot 에대해 Smith & Nephew, Inc. 가자발적현장안전시정조치를시작하였음을알리기위함입니다. 해당 제품은고정홈의위치가사양에맞지않게제조되었습니다. 사양에서벗어난상태는잠재적으로세가지기능장애중 하나를일으킬수있습니다 : 제품이결합되지않거나, 헤드가너무타이트하거나, 또는드문경우제품이결합된것처럼 보이지만차후수술후에분리될수있습니다. See Appendix 1 for full list of batch numbers. 배치번호의전체리스트는 Appendix 1 을참조하여주시기바랍니다. This field action has been reported to the relevant competent authorities. 본현장조치는관련규제기관에보고됩니다. Risks to Health 건강에대한위험 Actions to be taken by the user 사용자의조치 If the functional failure is not identified intra-operatively, the implanted assembly could potentially disassociate in the patient postoperatively, requiring a revision surgery. 만약수술중기능장애가확인되지않는다면, 이식된결합이잠재적으로수술후환자내에서 분리될수있으며, 재수술이필요할수있습니다. 1. Locate and quarantine affected unused devices immediately. 즉시사용되지않은제품을격리하여주시기바랍니다. 2. Return quarantined product to your national Smith & Nephew agency/distributor. 격리된제품을 Smith & Nephew 로돌려보내주시기바랍니다. 3. Complete the return slip and fax it to your national Smith & Nephew agency/distributor. 다음장의 Return slip 을작성하시어 Smith & Nephew 영업담당자또는 boram.park@smithnephew.com 으로전달하여주시기바랍니다. 4. Please make sure this safety information is passed on to all those who need to be aware of it within your organization. 본안전성정보를귀기관내모든관계자에게전달하여주시기바랍니다. 5. Please maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of the action. 본조치의효과를보장하기위하여해당안전조치가종료될때까지본공지사항및결과 조치에대한인식을유지하여주시기바랍니다. 2 / 8

3 If you have any questions please feel free to contact us under the following contact details: 질문의있으실경우아래의연락처로문의주시기바랍니다. 박보람, Quality Specialist 02) 김효경, Product Management Specialist 02) Return Slip 아래의내용을기입하신후 S&N 영업담당자또는 으로전달하여주시기바랍니다. HIP SYSTEM 에대한현장안전공지를인지하였음을확인합니다. 본현장안전공지는본기관내에커뮤니케이션되었습니다. * 해당란에표시하여주시기바랍니다 : 본기관은해당제품을보유하고있지않습니다. 아래의제품을반송할예정입니다. ( 아래표에수량을기입하여주시기바랍니다 ) 제품반송수량제품반송수량제품반송수량제품반송수량제품반송수량 기관명 : Reference: R 성명 : 일자및서명 : 3 / 8

4 Appendix 1 Affected Batch Numbers Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number AM AM13511A AM LM MM MM AM AM AM LM MM KM LM MM AM AM BM LM LM MM AM AM BM15318A LM06356A 13MM AM AM BM BM KM LM MM AM AM BM08940A KM LM MM AM AM KM24083A 13LM09236A 13MM09517A 14AM BM KM MM MM09517B 14AM02120A 14BM01133A LM MM MM AM BM LM MM02857A 13MM AM BM KM KM MM02862A 13MM AM BM KM LM MM MM AM BM KM LM MM09520A 13MM17943A 14AM BM KM LM MM AM AM KM MM MM AM02117A 14BM KM LM LM MM09524A 14AM BM KM LM MM02888A 13MM AM BM KM22756A 13LM09275A 13MM MM AM BM KM LM MM MM AM BM LM LM MM02893A 14AM BM LM00818A 13LM MM AM02121A 14BM LM LM11683A 13MM AM BM LM LM00817B 13LM MM AM BM16794A LM00809A 13LM09285A 13LM MM02901B 14BM BM LM LM LM MM BM BM16795A LM LM09289A 13LM MM BM LM00817A 13LM MM AM BM LM LM LM MM AM BM LM LM LM11730A 13MM AM BM LM LM11707A 13LM MM AM LM01883A 13LM LM MM BM LM LM LM MM MM13869A 13MM14122A LM LM LM MM MM BM LM01888A 13LM LM MM MM BM12178A LM LM LM MM MM LM LM LM MM MM LM LM LM15751A 13MM13871A 14BM LM LM12962A 13LM14032A 13LM MM BM LM12961A 13LM LM LM MM BM16796A LM LM LM14034A 13LM MM / 8

5 Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number LM AM AM AM BM12179A 14BM12182A LM AM02691A 14AM AM BM12179B 14BM12182B LM AM AM AM21695A 14BM LM16193A 14AM AM BM BM LM AM AM AM AM BM LM AM AM AM AM21696A 14BM KM LM AM AM02701B 14AM BM KM LM16204A 14AM AM AM LM MM AM AM02702A 14AM16937A LM16203A 14AM AM02701A 14AM BM LM AM02710A 14AM BM01110A 14BM AM AM BM BM01110B AM AM16597A LM LM BM BM LM AM AM08786A LM LM MM BM BM10265A 14BM LM MM AM BM BM BM LM MM AM BM BM10266A LM MM BM BM BM LM LM MM AM AM BM LM LM AM AM BM LM MM MM BM BM BM16819A LM14881A 13MM02907A 13MM BM BM BM LM MM MM09998A 14BM BM BM LM14883A 13MM AM BM BM BM LM MM AM BM BM LM LM MM MM MM AM LM LM19387A 13MM MM MM AM12038A LM17123A 13LM MM MM04126A 13MM08124A 14BM LM MM MM MM MM BM00775A LM MM04108A 13MM MM08116A 13MM BM LM MM MM MM MM LM MM MM04123A 13MM AM KM LM MM AM BM BM LM LM MM AM BM BM06977A LM LM MM AM BM BM LM LM MM04139A 14AM24084A 14BM BM LM LM MM AM BM BM LM LM MM AM BM BM LM LM AM AM BM BM LM MM AM AM BM BM LM MM04130A 14AM AM BM BM LM MM AM AM BM BM LM MM04132A 14AM BM BM BM LM17128A 13MM AM BM BM06975A 14DM / 8

6 Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number KM LM AM AM AM BM KM24095A 13LM AM AM AM BM KM LM17169A 14AM AM AM BM KM MM AM00485A 14AM02717A 14AM BM17712A LM AM AM AM BM BM LM AM AM00490A 14AM02718A 14BM KM LM MM AM02708A 14AM24102A 14BM KM LM MM AM AM BM KM LM15743A 13MM AM AM24103A 14BM LM LM MM AM16514A 14AM BM14324A LM LM15745A 13MM AM AM BM LM LM MM AM BM BM LM LM AM AM BM BM LM11741A 13MM AM AM BM LM MM AM AM BM LM MM AM AM BM04024A LM15741A 13MM AM AM BM LM LM MM AM AM BM LM LM MM AM BM LM MM MM AM16526A 14BM LM MM MM18008A 14AM16526B 14BM14333A LM LM MM13695A 14AM00586B 14AM BM LM LM AM AM BM BM LM LM AM AM BM03036A 14BM08988A LM LM14910A 14AM AM BM BM LM MM AM AM12014A 14BM08979A 14BM LM14905A 13MM AM AM BM08979B 14BM LM MM AM AM BM BM LM14906A 13MM AM AM BM BM MM MM MM MM BM MM MM10147A 13MM MM BM15222A MM10143A 13MM MM BM KM20614A 13LM07412A 14AM AM12027A 14BM03022A 14BM KM LM07413A 14AM AM BM03022B 14BM LM LM AM AM BM BM LM LM07414B 14AM BM BM03023A 14BM LM LM AM BM BM LM06371A 13LM07415A 14AM BM03021A 14BM03025A LM AM AM BM BM LM LM AM BM BM15249A 14BM LM AM AM02685A 14BM BM / 8

7 Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number LM LM MM13701A 14BM BM BM LM07419B 13MM AM BM BM CM LM07420B 13MM AM BM BM LM07420D 13MM AM BM BM19328A LM MM13700A 14AM BM BM19328B LM MM AM BM BM LM LM LM04207A 13LM AM BM LM LM AM BM BM BM LM LM14911A 14AM BM10269A 14BM BM KM22761A 13KM22761C 13LM04199A 13MM BM KM22761B 13KM MM BM LM AM AM BM BM BM00731A LM MM15827A 14AM AM MM AM AM14596A 14BM LM MM AM BM BM LM AM AM BM BM05787A LM LM14007A 13MM AM AM LM MM AM AM BM LM MM01324A 14AM AM LM LM LM AM AM BM LM LM LM AM AM BM LM LM LM AM AM BM LM LM12933A 14AM AM AM BM LM LM AM05505A 14AM15505A 14AM BM LM LM AM AM AM LM AM AM AM BM LM AM AM AM BM LM AM AM15503A 14AM16955A 14BM LM AM AM AM BM11540A KM MM MM08136A 14AM13561A 14AM AM LM MM MM AM13561B 14AM BM LM MM AM AM AM BM LM MM AM AM AM BM LM MM08135A 14AM13560A 14AM AM16971A MM MM AM AM AM LM LM19404A 13MM AM AM BM LM LM AM AM AM BM LM MM AM AM AM16973A 14BM03988A LM MM AM AM16537A 14AM BM LM MM08034A 14AM13563A 14AM BM LM LM MM AM AM BM LM MM AM AM AM23073A 14BM LM MM AM AM AM LM MM09245A 14AM AM16976A 14AM23076A 7 / 8

8 Material Number Batch Number Batch Number Batch Number Batch Number Batch Number Batch Number LM AM AM AM13566A 14AM LM AM AM AM BM LM13912A 14AM AM AM LM MM AM05514A 14AM BM LM13988A 13MM09279A 14AM AM BM LM AM AM16979A 14AM BM11533A LM AM AM AM23084A 14CM LM LM05332A 13MM AM AM LM05330A 13LM MM AM AM LM LM13904A 14AM AM AM LM LM LM13897A 14AM BM LM03426A 13LM LM13897B 14AM16990A 14BM LM LM AM AM BM10262A LM03430A 13LM AM AM LM LM AM AM AM16993A 14AM LM LM AM AM AM BM LM LM AM AM BM LM03434A 14AM AM AM LM AM05474A 14AM BM11539A 14BM11539D MM AM AM15517A 14BM11539B AM AM BM BM11539C LM AM AM BM LM MM01365A 14AM BM MM AM AM BM BM00722A LM / 8

사용시 기본적인 주의사항 경고 : 전기 기구를 사용할 때는 다음의 기본적인 주의 사항을 반드시 유의하여야 합니다..제품을 사용하기 전에 반드시 사용법을 정독하십시오. 2.물과 가까운 곳, 욕실이나 부엌 그리고 수영장 같은 곳에서 제품을 사용하지 마십시오. 3.이 제품은

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