令和 3年 5月27日作成

一般的名称： 滅菌済み絹製縫合糸
販売名　　： マニーシルク

回収数量
3,632,362個

対象品番
4-0シルク ブラック・ブレイド, 4-0シルク ブラック片端針, 4-0シルク ホワイト・ブレイド, 5-0シルク ブラ
ック・ブレイド, 5-0シルク ブラック片端針
, 6-0シルク ブラック・ブレイド, 6-0シルク ブラック片端針, 7-0シルク ブラック・ブレイド, 7-0シルク ブ
ラック・ブレイド糸30cm, 7-0シルク ブ
ラック片端針, 7-0シルク ホワイト片端針, 8-0シルク ブラック・ブレイド, 8-0シルク ブラック片端針, 滅菌
済針付縫合糸 No.１, 滅菌
済針付縫合糸 No.１０, 滅菌済針付縫合糸 No.１１, 滅菌済針付縫合糸 No.１４, 滅菌済針付縫合糸 No.１７, 
滅
菌済針付縫合糸 No.２, 滅菌済針付縫合糸 No.２０, 滅菌済針付縫合糸 No.２２, 滅菌済針付縫合糸 No.２４, 
滅菌
済針付縫合糸 No.２４Ｌ, 滅菌済針付縫合糸 No.２５, 滅菌済針付縫合糸 No.２６, 滅菌済針付縫合糸 No.２７
, 滅
菌済針付縫合糸 No.２８, 滅菌済針付縫合糸 No.２９, 滅菌済針付縫合糸 No.３, 滅菌済針付縫合糸 No.３０, 
滅菌
済針付縫合糸 No.３４, 滅菌済針付縫合糸 No.３７, 滅菌済針付縫合糸 No.５, 滅菌済針付縫合糸 No.６

対象ロット
716D001500, 716D001600, 716D001700, 716D001900, 716D002200, 716D002300, 716D002400, 716D002500, 716D
002600, 716D002700, 716E000800, 716E000900, 716E001000, 716E001100, 716E001400, 716E001500, 716E0021
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716F002300, 716G000600, 716G000700, 716G000800, 716G001000, 716G001100, 716G001200, 716G001300, 716G
003300, 716G003500, 716G003800, 716G003900, 716G004000, 716H000100, 716H000400, 716H000500, 716H0006
00, 716H000700, 716H000900, 716H001000, 716H002300, 716H002400, 716H002500, 716H002600, 716I000200,
716I000600, 716I000700, 716I000800, 716I000900, 716I001000, 716I001100, 716I001200, 716I001300, 716I
001400, 716I003000, 716I003100, 716I003300, 716I003400, 716I003600, 716I003700, 716I004100, 716I0042
00, 716I004300, 716I004400, 716I004500, 716J000100, 716J000200, 716J000300, 716J000500, 716J000600,
716J000700, 716J001600, 716J001700, 716J001800, 716J001900, 716J002100, 716J002200, 716J002300, 716J
002500, 716J002600, 716J002700, 716J003000, 716J003100, 716J005000, 716J005300, 716K000100, 716K0005
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716K002600, 716K002700, 716K002800, 716K003600, 716K003700, 716K003800, 716K003900, 716K004000, 716K
004100, 716K004200, 716L000200, 716L000300, 716L000400, 716L000500, 716L000800, 716L000900, 716L0010
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716L003300, 716L003400, 716L003500, 717A003900, 717A004200, 717A004500, 717A004600, 717A004700, 717A
004900, 717A005000, 717A005100, 717A005200, 717A005300, 717A005700, 717A006000, 717A006100, 717A0063
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717B000400, 717B000600, 717B000900, 717B001200, 717B001300, 717B001400, 717B001600, 717B001700, 717B
001800, 717B002100, 717B003400, 717C000500, 717C000600, 717C000700, 717C000900, 717C001300, 717C0014
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001100, 717D001200, 717D001300, 717D001400, 717D001500, 717D001600, 717D001700, 717D002000, 717D0021
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000800, 717G001000, 717G001100, 717G001200, 717G001300, 717H001700, 717H001800, 717H002000, 717H0022
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001800, 717I001900, 717I002000, 717I002100, 717I002200, 717I002400, 717I002500, 717I002600, 717I0030
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717I004600, 717I004700, 717I004800, 717I004900, 717I005000, 717I005100, 717I005200, 717I007400, 717I
007500, 717J000200, 717J000300, 717J000500, 717J000600, 717J000700, 717J000800, 717J000900, 717J0013
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717J002600, 717J003300, 717J003400, 717J003500, 717J003600, 717J003900, 717J004100, 717J005500, 717K
000100, 717K000200, 717K000300, 717K000500, 717K000700, 717K000800, 717K000900, 717K001000, 717K0013
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001700, 717L001800, 717L002100, 717L002200, 717L002300, 717L002700, 717L002800, 717L003000, 717L0033
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717L007700, 717L007800, 717L007900, 717L008000, 717L008200, 718A000300, 718A000400, 718A000500, 718A
000600, 718A000700, 718A001000, 718A001300, 718A001400, 718A001500, 718A001800, 718A001900, 718A0020
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000400, 718B000500, 718B000900, 718B001000, 718B001200, 718B001300, 718B002100, 718B002200, 718B0023
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006300, 718C006400, 718C006500, 718D000100, 718D000200, 718D000700, 718D001000, 718D001200, 718D0013
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718E002300, 718E002500, 718E002700, 718E002800, 718E003000, 718E003100, 718E003200, 718E003300, 718E
003600, 718E004000, 718E004100, 718E004400, 718E004500, 718E004600, 718E004700, 718E004800, 718E0049
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718E006900, 718F000100, 718F000200, 718F000300, 718F000500, 718F001300, 718F002500, 718F002600, 718F
002700, 718G000600, 718G000700, 718G000800, 718G000900, 718G001000, 718G001100, 718G001400, 718G0021
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002700, 718H002800, 718H003000, 718H003200, 718H003400, 718H004500, 718H004600, 718H004800, 718H0050
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718I001400, 718I001500, 718I002500, 718I002700, 718I002800, 718I002900, 718I003400, 718I003500, 718I
003600, 718I003700, 718J000100, 718J000200, 718J000300, 718J000400, 718J000500, 718J000600, 718J0008
00, 718J001000, 718J001400, 718J001500, 718J001600, 718J001800, 718J001900, 718J002400, 718J002800,
718K000100, 718K000200, 718K000300, 718K000600, 718K000700, 718K000800, 718K000900, 718K001000, 718K
003300, 718K003400, 718K003600, 718K003800, 718L000100, 718L000200, 718L000300, 718L000400, 718L0007
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718L005800, 718L006200, 718L006400, 718L006700, 718L007000, 718L007100, 719A000100, 719A000200, 719A
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719B001000, 719B001100, 719B001200, 719B002800, 719B002900, 719B003200, 719B003300, 719B003500, 719B
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001900, 719D002200, 719D002300, 719D005900, 719D006000, 719D006200, 719D006300, 719D006400, 719D0065
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002000, 719H002100, 719H002200, 719H002300, 719H002400, 719H004000, 719H004100, 719H004300, 719I0006
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719I003000, 719I003100, 719I003200, 719I006200, 719I006300, 719I006400, 719I006600, 719I006800, 719J
000100, 719J000200, 719J000300, 719J000400, 719J000500, 719J000600, 719J000700, 719J000800, 719J0009
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007300, 719L007400, 720A000300, 720A000400, 720A000600, 720A000700, 720A000800, 720A000900, 720A0013
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000300, 720G000500, 720G000600, 720G000700, 720G000800, 720G000900, 720G001000, 720G001100, 720G0012
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045800, Z160049400, Z160051400, Z160051700, Z160054900, Z160057900, Z160058100, Z160061400, Z1600623
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Z160070400, Z160070500, Z160070700, Z160070900, Z160071100, Z160078100, Z160081400, Z160081900, Z160
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025500, Z170025600, Z170026300, Z170026600, Z170032900, Z170034300, Z170034600, Z170034700, Z1700348
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Z170042800, Z170043100, Z170045900, Z170046000, Z170047500, Z170047900, Z170048900, Z170050100, Z170
052800, Z170054600, Z170055000, Z170056500, Z170057200, Z170057300, Z170057500, Z170060800, Z1700648
00, Z170064900, Z170065400, Z170067800, Z170069300, Z170069600, Z170071200, Z170072700, Z170073000,
Z170075300, Z170075500, Z170075600, Z170075900, Z170076100, Z170078200, Z170078300, Z170079400, Z170
079500, Z170079800, Z170080700, Z170080800, Z170081300, Z170081400, Z170084900, Z170085900, Z1700870
00, Z170091500, Z170093200, Z170094000, Z170094300, Z170094400, Z170096500, Z170096600, Z170100100,
Z170102800, Z170103100, Z170103900, Z170104000, Z170109800, Z170112200, Z170112300, Z180112600, Z180
113100, Z180113200, Z180114600, Z180114800, Z180114900, Z180119700, Z180119900, Z180120000, Z1801205
00, Z180121700, Z180122100, Z180122300, Z180125700, Z180127400, Z180128900, Z180129500, Z180132000,
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出荷時期
平成18年6月〜令和3年5月

製造販売業者の名称　： マニー株式会社
製造販売業者の所在地： 栃木県宇都宮市清原工業団地8番3
許可の種類　　　　　： 第一種医療機器製造販売業
許可番号　　　　　　： 09B1X00006

本品のマルチフィラメント縫合糸において、製造時に縫合糸の端面を硬化させる目的で使用され、最終製品の一
部となる接着剤が、本品の構成品として承認書に記載されていないことが社内の点検作業にて判明しましたので
、自主回収を実施いたします。

本接着剤は、針元及び後端面から数ミリ〜十数ミリの範囲で縫合糸に塗布されています。針元に塗布され硬化し
た接着剤が、縫合時に血液・体液・粘膜等に接触しますが、接触時間はごく僅かで、当該接着剤が塗布された部
分は埋植されないことから、本品の使用により重篤な健康被害に至る可能性はないと判断しております。
なお、現在までに本接着剤に起因する健康被害発生の報告はありません。

令和3年5月19日　（情報提供開始日）

手術用縫合

速やかに自主回収を行う旨を通知し、回収作業を行います。

担当者　： 品質管理グループ　金子典夫
連絡先　： マニー株式会社
　　　　　 栃木県宇都宮市清原工業団地8番3
電話番号： 028-667-1811
FAX番号 ： 028-667-9267