URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action / Recall

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Curtis Murphy
5 years ago
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1 November 16, 2016 URGENT FIELD SAFETY NOTICE: Medical Device Field Safety Corrective Action / Recall Reference: R Concerned Devices: REFLECTION Dead Blow Mallet Product No. Description Product No Reflection Dead Blow Mallet See attached Dear Dr. This letter is to inform you that Smith & Nephew, Inc. has initiated a voluntary field safety corrective action of its DEAD BLOW MALLET ( the Mallet ). A number of complaints have been received in relation to cracking of the welds on the head of the Mallet. In a small number of reported cases, the cracks in the welding resulted in some lead beads escaping from the head of the Mallet. Context The Mallet is a standard surgical instrument used mostly in hip replacement surgery for general impaction of broaches and of hip implants. It was first placed on the market by Smith & Nephew in This field action has been reported to the relevant competent authorities. Risks to Health Actions to be taken by the user Smith & Nephew has received a small number of complaints reporting cracks the welds located on the head of the mallet which is filled with lead beads. In the reported cases some of the lead beads and particles escaped from the mallet into the surgical wound. As these failures occurred intraoperatively and appropriate actions were taken to remove the lead beads from the wound during surgery, no further adverse effects were reported. Smith & Nephew is recalling the mallets as the risk of lead escaping from the mallet and the potential adverse effects associated with lead exposure were previously unidentified risks. Based on the low occurrence (0.03%) of the worst case failure mode defined above and the high detectability should any lead beads escape into the surgical wound, no proactive followup is recommended. 1. Locate and quarantine affected devices immediately. 2. Return quarantined product to your national Smith & Nephew agency/distributor. 3. Complete the return slip and fax it to your national Smith & Nephew contact below. 4. Please make sure this safety information is passed on to all those who need to be aware of it within your organization. 5. Please maintain awareness on this notice and resulting action until the Field Safety Corrective Action is terminated to ensure effectiveness of the action.

2 If you have any questions please feel free to contact us under the following contact details: Smith & Nephew Advanced Surgical Devices UK & I greg.williams@smith-nephew.com Fax: + 44 (0) Return Slip Please complete and return this feedback information to the contact specified above to prevent repetitive enquires. We hereby confirm that we are aware of this Field Safety Notice concerning the REFLECTION Dead Blow Mallet. The Field Safety Notice was communicated within our organisation. Please mark accordingly: In our facility we do not have any of the affected product in stock or We will return the following products: Product Description Lot Number Number Returned Reflection Dead Blow Mallet Institution: Reference: R Name: Date / Signature: Appendix 1 Affected Batch Numbers

3 Item Reflection Dead Blow Mallet Affected Batches A 01BM BM GM GM GM GM JM DM DM EM FM LM LM LM MM MM02211A 03CM EM HM KM AM BM DM DM DM EM EM GM GM GM GM GM KM KM KM MM MM AM AM AM AM AM AM14646A 05EM EM FM FM GM GM GM GM GM GM GM GM GM GM GM GM GM GM HM HM HM HM HM HM HM HM HM HM HM HM JM JM LM LM LM MM MM MM AM MM DM FM AM EM MM DM GM AM EM MM DM GM AM EM23207A 06AM DM GM AM EM AM DM GM BM FM AM DM HM BM FM BM DM HM BM FM BM DM HM CM FM22177R 06BM EM HM CM FM DM EM HM CM FM DM EM HM CM FM22180R 06DM EM KM CM FM DM EM KM CM FM22181R 06DM EM KM DM GM DM EM KM DM JM DM EM KM DM JM DM EM LM DM JM DM EM LM DM JM DM EM MM EM JM DM EM MM EM JM DM EM AM EM JM08254R

4 06DM FM AM EM JM KM GM EM MM MM KM GM EM MM BM KM GM EM MM BM KM GM EM AM BM KM HC EYW AM08358A 12BM KM HM EYW0009A 11AM BM KM HM EYW0009B 11AM08359A 12BM KM HM EYW0009C 11AM CM KM HM EYW0009D 11AM DM LM HM EYW0009E 11AM DM05835A 07LM HM EYW AM DM LM HM EYW0010A 11AM DM05836A 07LM HM EYW0010B 11AM DM LM HM EYW0010C 11AM10566A 12DM LM HM EYW AM DM LM HM EYW0011A 11AM DM10420A 07LM HM EYW0011B 11CM EM LM HM EYW0011C 11CM EM LM HM EYW0011D 11CM EM00717A 07LM HM EYW0011E 11DM EM MM MM EYW0011F 11EM EM MM MM15605A 09EYW EM EM MM13911R 08MM EYW0012A 11FM EM MM MM EYW0012B 11FM EM MM13912R 08MM EYW0012C 11FM GM MM MM EYW0012D 11FM GM MM AM EYW GM HM MM AM EYW0013A 11GM HM MM13917R 09BM EYW0013B 11GM HM06213A 08AM BM EYW0013C 11GM HM EM BM MM HM HM EM BM GM HM HM FM BM GM HM HM FM BM HM HM HM FM BM HM HM HM11857R 08FM BMI HM HM15620A 12JM FM BMI HM JM JM FM BMI HM08505R 11KM JM00569A 08FM BMO HM KM JM FM BMO HM11149R 11KM JM FM CM HM KM JM FM CM HM16824R 11KM JM FM CM HM16824S 11MM JM FM CMI LM MM06746A 12JM GM DM MM MM JM04983

5 08GM DM MM MM GM DM MM MM KM BM MM BM KM BM MM BM KM BM AM BM LM BM AM BM LM BM CM CM LM BM DM CM BM BM DM CM CM BM DM CM CM BM DM EM DM BM DM EM DM BM DM EM DM BM04160R 15DM EM DM CM EM EM DM CM FM EM DM DM FM EM DM20982A 14DM JM FM EM DM JM FM EM DM JM FM FM EM JM FM FM EM JM FM FM EM JM FM FM18102A 14EM JM FM GM EM JM FM GM EM JM FM GM FM JM GM GM FM JM GM HM FM JM GM HM GM JM A 13HM GM JM A 13JM GM JM A 13JM GM JM A 13JM GM JM A 13JM GM JM A 13KM HM JM AM KM HM LM BM KM JM LM BM KM JM LM LM KM JM LM LM LM LM LM MM LM LM01406R 15LM BM MM LM MM BM MM LM MM BM MM LM MM KM AM LM AM KM16513

Kimal plc: URGENT FIELD SAFETY NOTICE Field Safety Corrective Action IMMEDIATE ACTION REQUIRED

(Customer Name) (Address Line 1) (Address Line 2) (Address Line 3) (Address Line 4) (Post Code) Kimal plc: URGENT FIELD SAFETY NOTICE Field Safety Corrective Action IMMEDIATE ACTION REQUIRED Adult Altius