BRÅDKSANDE MEDDELANDE ÅTERKALLANDE AV MEDICIN TEKNISK PRODUKT

Transkript

1 Synthes GmbH Luzernstrasse Zuchwil Switzerland Tel Fax Till ansvarig på Operationsavdelningen: 19 January 2014 BRÅDKSANDE MEDDELANDE ÅTERKALLANDE AV MEDICIN TEKNISK PRODUKT Artikelnummer/Beskrivning Artikelnummer Beskrivning QD8-2SB-C-8F 2 mm Carbide Fluted Ball, Standard, 8 Flutes. Use with QD8 QD8-4B-C-10F 4 mm Carbide Fluted Ball, 10 Flutes. Use with QD8 QD8-5B-C-10F 5 mm Carbide Fluted Ball, 10 Flutes. Use with QD8 QD8-7B-C-14F 7 mm Carbide Fluted Ball, 14 Flutes. Use with QD8 S-15DRMC 1.5 mm x 7.5 mm Cylindrical Carbide Drum. Use with SHORT S-15DRMC-L 1.5 mm x 7.5 mm Cylindrical Carbide Drum, Extends 25 mm. Use with SHORT S-1B-C 1 mm Carbide Fluted Ball, Extended Length. Use with SHORT S-1SB-C 1 mm Carbide Fluted Ball, Standard Length. Use with SHORT S-2B-C 2 mm Carbide Fluted Ball, Extended Length. Use with SHORT S-2SB-C 2 mm Carbide Fluted Ball, Standard Length. Use with SHORT S-3B-C 3 mm Carbide Fluted Ball, Extended Length. Use with SHORT S-3SB-C 3 mm Carbide Fluted Ball, Standard Length. Use with SHORT S-4B-C 4 mm Carbide Fluted Ball, Standard Length. Use with SHORT S-4BL-C 4 mm Carbide Fluted Ball, Extends 27 mm. Use with SHORT S-5B-C 5 mm Carbide Fluted Ball, Standard Length. Use with SHORT S-6B-C 6 mm Carbide Fluted Ball, Standard Length. Use with SHORT S-7B-C 7 mm Carbide Fluted Ball, Standard Length. Use with SHORT Lot Nummmer

2 Page 2 of 8 Bästa mottagare, Synthes GmbH som företräder Anspach inleder en frivillig återkallelse av ovan nämnda artiklar och LOT nummer av Anspach Short Carbide Cutting Burrs. Enligt våra register har Ni erhållit en produkt/produkter från de partier (LOT nr) som nämns ovan. Beskrivninv av problem: Lasermarkeringens placering på Anspach Short Carbide Skär Burrs är utanför validerad specifikation och kan leda till en potentiell fraktur på borrens distala del. Potentiell fara: Potentiella skador som identifierats vid fraktur inkluderar reoperation på grund av kvarvarande fragment, mjukvävnadsskada på grund av lösa fragment och försening av kirurgi. Kundens omedelbara åtgärd: 1. DePuy Synthes ber Er omedelbart undersöka och plocka bort alla produkter som anges ovan på ett sätt som säkerställer att de berörda produkterna inte kommer att användas. 2. Läs igenom, fyll i, signera och returnera bifogat svarsformulär till din lokala DePuy Synthes säljorganisation enligt anvisningarna på blanketten inom 5 arbetsdagar efter mottagandet av denna information. DePuySynthes Att: Lisa Helander Korta Gatan Solna Fax nr: Returnera berörda produkter inom 30 arbetsdagar. En kreditnota kommer att utfärdas för de returnerade produkterna. 4. Vidarebefordra detta meddelande till alla som behöver informeras. 5. Om någon produkt som anges nedan har skickats till en annan avdelning, var vänlig kontakta vederbörande för att ordna med retur. 6. Observera att detta meddelande är gällande tills alla nedanstående produkter returnerats till Synthes GmbH. 7. Behåll en kopia av detta meddelande.

3 Page 3 of 8 Vi ber om ursäkt för eventuella olägenheter som detta kan orsaka, och tackar på förhand för er uppmärksamhet och ert samarbete. För vidare information, kontakta Produkt Specialist Power Tools, Ulf Uggla tel: Med vänlig hälsning Anne-Katrine Udjus Business Unit Director Neuro/Power Tools Cc Hillevi Peltola Quality and Regulatory Manager Nordics

4 Page 4 of 8 VIKTIGT MEDDELANDE ÅTERKALLANDE AV MEDICIN TEKNISK PRODUKT R Anspach Short Carbide Cutting Burrs Verifieringsavsnitt Arikelnummer Lot nummer Artikelnummer Lot Nummer QD8-2SB-C-8F se lista S-2SB-C se lista QD8-4B-C-10F se lista S-3B-C se lista QD8-5B-C-10F se lista S-3SB-C se lista QD8-7B-C-14F se lista S-4B-C se lista S-15DRMC-L se lista S-4BL-C se lista S-15DRMC se lista S-5B-C se lista S-1B-C se lista S-6B-C se lista S-1SB-C se lista S-7B-C se lista S-2B-C se lista - - Vi har funnit den identifierade produkten i lager, returnerad kvantitet dokumenteras nedan, en kopia av detta brev bevaras för våra register. Vi har inte någon identifierad produkt på lager, returnerad kvantitet är noll, en kopia av detta brev bevaras för våra register. RETURNERADE PRODUKTER (inklusive antal) och/eller KOMMENTARER: Sjukhus namn: Namn/Titel (vänligen texta) Telefon Nummer: Signatur och Datum:

5 Page 5 of 8 Lista av berörda artiklar och LOT nummer: Artikelnummer Beskrivning LOT nummer S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM D S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM D S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM D S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM E S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM E S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM E S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM E S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM E S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM F S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM F S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM B S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM E S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM F S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM E S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM E S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM F S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM F S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM F S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM G S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM G S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM F S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM G S-15DRMC 1.5MM X 7.5MM CYL CARBIDE DRUM G S-15DRMC-L 1.5MM X 7.5MM CYLINDRICAL CARBIDE DRUM, E S-15DRMC-L 1.5MM X 7.5MM CYLINDRICAL CARBIDE DRUM, G S-1B-C 1MM CARBIDE FLUTED BALL, EXTENDED F S-1B-C 1MM CARBIDE FLUTED BALL, EXTENDED G S-1B-C 1MM CARBIDE FLUTED BALL, EXTENDED E S-1SB-C 1MM CARBIDE FLUTED BALL E S-1SB-C 1MM CARBIDE FLUTED BALL E S-1SB-C 1MM CARBIDE FLUTED BALL E S-1SB-C 1MM CARBIDE FLUTED BALL E S-1SB-C 1MM CARBIDE FLUTED BALL E S-1SB-C 1MM CARBIDE FLUTED BALL E

6 Page 6 of 8 S-1SB-C 1MM CARBIDE FLUTED BALL E S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED B S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED B S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED C S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED C S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED C S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED C S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED C S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED D S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED D S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED D S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED D S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED D S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED E S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED E S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED E S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED E S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED G S-2B-C 2MM CARBIDE FLUTED BALL, EXTENDED E S-2SB-C 2MM CARBIDE FLUTED BALL E S-2SB-C 2MM CARBIDE FLUTED BALL E S-2SB-C 2MM CARBIDE FLUTED BALL S-2SB-C 2MM CARBIDE FLUTED BALL F S-2SB-C 2MM CARBIDE FLUTED BALL E S-2SB-C 2MM CARBIDE FLUTED BALL E S-2SB-C 2MM CARBIDE FLUTED BALL G S-2SB-C 2MM CARBIDE FLUTED BALL F S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED B S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED B S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED B S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED B S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED C S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED C S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED D S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED D S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED D S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED D S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED D S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED E S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED E S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED E S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED G S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED G S-3B-C 3MM CARBIDE FLUTED BALL, EXTENDED E S-3SB-C 3MM CARBIDE FLUTED BALL C S-3SB-C 3MM CARBIDE FLUTED BALL C

7 Page 7 of 8 S-3SB-C 3MM CARBIDE FLUTED BALL C S-3SB-C 3MM CARBIDE FLUTED BALL C S-3SB-C 3MM CARBIDE FLUTED BALL E S-3SB-C 3MM CARBIDE FLUTED BALL E S-3SB-C 3MM CARBIDE FLUTED BALL E S-3SB-C 3MM CARBIDE FLUTED BALL F S-3SB-C 3MM CARBIDE FLUTED BALL E S-4B-C 4MM CARBIDE FLUTED BALL C S-4B-C 4MM CARBIDE FLUTED BALL C S-4B-C 4MM CARBIDE FLUTED BALL E S-4B-C 4MM CARBIDE FLUTED BALL F S-4B-C 4MM CARBIDE FLUTED BALL E S-4B-C 4MM CARBIDE FLUTED BALL G S-4B-C 4MM CARBIDE FLUTED BALL F S-4B-C 4MM CARBIDE FLUTED BALL G S-4B-C 4MM CARBIDE FLUTED BALL G S-4B-C 4MM CARBIDE FLUTED BALL G S-4B-C 4MM CARBIDE FLUTED BALL G S-4B-C 4MM CARBIDE FLUTED BALL E S-4B-C 4MM CARBIDE FLUTED BALL G S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM C S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM D S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM D S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM E S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM E S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM B S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM E S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM D S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM E S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM D S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM G S-4BL-C 4MM CARBIDE FLUTED BALL, EXT 27MM D S-5B-C 5MM CARBIDE FLUTED BALL B S-5B-C 5MM CARBIDE FLUTED BALL B S-5B-C 5MM CARBIDE FLUTED BALL B S-5B-C 5MM CARBIDE FLUTED BALL B S-5B-C 5MM CARBIDE FLUTED BALL C S-5B-C 5MM CARBIDE FLUTED BALL C S-5B-C 5MM CARBIDE FLUTED BALL E S-5B-C 5MM CARBIDE FLUTED BALL E S-5B-C 5MM CARBIDE FLUTED BALL E S-5B-C 5MM CARBIDE FLUTED BALL E S-5B-C 5MM CARBIDE FLUTED BALL F S-5B-C 5MM CARBIDE FLUTED BALL G S-5B-C 5MM CARBIDE FLUTED BALL E S-5B-C 5MM CARBIDE FLUTED BALL G

8 Page 8 of 8 S-6B-C 6MM CARBIDE FLUTED BALL C S-6B-C 6MM CARBIDE FLUTED BALL C S-6B-C 6MM CARBIDE FLUTED BALL D S-6B-C 6MM CARBIDE FLUTED BALL D S-6B-C 6MM CARBIDE FLUTED BALL E S-6B-C 6MM CARBIDE FLUTED BALL S-6B-C 6MM CARBIDE FLUTED BALL F S-6B-C 6MM CARBIDE FLUTED BALL F S-6B-C 6MM CARBIDE FLUTED BALL F S-6B-C 6MM CARBIDE FLUTED BALL D S-6B-C 6MM CARBIDE FLUTED BALL D S-6B-C 6MM CARBIDE FLUTED BALL E S-6B-C 6MM CARBIDE FLUTED BALL D S-7B-C 7MM CARBIDE FLUTED BALL E S-7B-C 7MM CARBIDE FLUTED BALL E S-7B-C 7MM CARBIDE FLUTED BALL E S-7B-C 7MM CARBIDE FLUTED BALL E S-7B-C 7MM CARBIDE FLUTED BALL F S-7B-C 7MM CARBIDE FLUTED BALL E S-7B-C 7MM CARBIDE FLUTED BALL E S-7B-C 7MM CARBIDE FLUTED BALL E