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U.S. Department of Health and Human Services

Class 2 Device Recall Sofsilk Braided Silk sutures

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  Class 2 Device Recall Sofsilk Braided Silk sutures see related information
Date Initiated by Firm December 21, 2023
Date Posted January 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-0845-2024
Recall Event ID 93768
510(K)Number K981128  
Product Classification Suture, nonabsorbable, silk - Product Code GAP
Product Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 S-246 SOFSILK* 0 BLK 6X60CM PCT X36 S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 S-316 SOFSILK* 0 BLK 12X75CM PCT X24 S-317 SOFSILK* 1 BLK 12X75CM PCT X24 S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 S-606 SOFSILK* 0 BLK 2X150CM PCT X36 S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 S-610 SOFSILK* 5 BLK 2X150CM PCT X12 SOFSILK 2-0 30 BK CV-24 GS453-2 SOFSLK 4-0 24 BK CV-15 DA VS581-2 ***Added 4/1/24*** CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 S-187 SOFSILK* 1 BLK 6X45CM PCT X36 S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA S-282 SOFSILK* 5 BLK 3X60CM PCT X36 S-318 SOFSILK* 2 BLK 12X75CM PCT X24 S-608 SOFSILK* 2 BLK 2X150CM PCT X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 XX-5280 SOFSILK* 0 BLK 150CM PCT X36 -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA 3226-31 TICRON* 4-0 BLU 60CM CV330 DA 88863026-71 TICRON* 1 BLU 75CM HOS12X36 88863070-51 TICRON* 2-0 BLU 75CM C15X36 88863087-31 TICRON* 4-0 BLU 75CM CV33DA 88863092-71 TICRON* 1 BLU 75CM KV37X36 88863147-83 TICRON 2 BLU 5X75CM KV37X12 88863185-41 TICRON* 3-0 BLU 75CM CV305 88863186-31 TICRON* 4-0 BLU 75CM CV331 88863226-31 TICRON* 4-0 BLU 60CM CV330DA 88863226-41 TICRON* 3-0 BLU 60CM CV330DA 88863229-31 TICRON* 4-0 BLU 75CM CV307DA 88863271-31 TICRON* 4-0 BLU 90CM CV331DA 88863309-71 TICRON* 1 BLU 75CM GS11X36 -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12
Code Information Model CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 UDI-DI 20884521083629 Lot D1L1576RY Model GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 UDI-DI 20884521085203 Lot D2B1216RY Model S-176 SOFSILK* 0 BLK 12X45CM PCT X24 UDI-DI 20884521085746 Lot D2D0612RY Model S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 UDI-DI 20884521085944 Lot D2B0728RY Model S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 UDI-DI 20884521085968 Lots D2D0972RY D2E2396RY Model S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 UDI-DI 20884521085975 Lots D2D0957RY D2D0968RY D2D0971RY D2D0984RY D2D0985RY D2E0900RY D2E0902RY Model S-245 SOFSILK* 2-0 BLK 12X60CM PCT X36 UDI-DI 10884521086197 Lot D2E0674RY UDI-DI 20884521086194 Lots D2D1871RY D2E0674RY D2E0901RY Model S-246 SOFSILK* 0 BLK 6X60CM PCT X36 UDI-DI 20884521086200 Lot D2D0980RY Model S-2782K SOFSILK* 4-0 WHI 45CM SS24 DA UDI-DI 20884521086422 Lot D2F2101RY Model S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 UDI-DI 20884521086460 Lots D2D1872RY D2D2120RY Model S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 UDI-DI 20884521086477 Lot D2D1991RY Model S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 UDI-DI 20884521086484 Lots D2E0907RY D2E2685RY Model S-316 SOFSILK* 0 BLK 12X75CM PCT X24 UDI-DI 20884521086491 Lot D2D2436RY Model S-317 SOFSILK* 1 BLK 12X75CM PCT X24 UDI-DI 20884521086514 Lot D2E0587RY Model S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 UDI-DI 20884521086620 Lot D2E0676RY Model S-606 SOFSILK* 0 BLK 2X150CM PCT X36 UDI-DI 10884521086630 Lot D2B2638RY UDI-DI 20884521086637 Lots D2B2638RY D2D0961RY Model S606-12 SOFSILK* 0 BLK 2X150CM PCT X12 UDI-DI 10884521637887 Lot D2D0961RY Model S-610 SOFSILK* 5 BLK 2X150CM PCT X12 UDI-DI 20884521086675 Lot D2B1535RY Model SOFSILK 2-0 30 BK CV-24 GS453-2 UDI-DI 20884521758121 Lots D2D0254RY D2D1576RY Model SOFSLK 4-0 24 BK CV-15 DA VS581-2 UDI-DI 20884521757971 Lot D2E1431RY ***Added 4/1/24*** Model CS-792 SOFSILK* 0 BLK 100CM GCC90 X36 UDI-DI 20884521084756 Lot D2C0576RY Model S-1172 SOFSILK* 6-0 BLK 45CM C1 X36 UDI-DI 20884521085470 Lot D2J0691RY Model S-1735 SOFSILK* 4-0 BLK 30CM C1 DA X12 UDI-DI 20884521085630 Lot D1L3318FRY Model S-1750K SOFSILK* 6-0 BLK 45CM HE1 DAX12 UDI-DI 20884521085739 Lot D2E2348RY Model S-1768K SOFSILK* 7-0 BLK 45CM HE6 DAX12 UDI-DI 20884521085784 Lot D2B2217RY Model S-1789K SOFSILK* 4-0 BLK 45CM HE3 X12 UDI-DI 20884521085876 Lot D2D0262RY Model S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 UDI-DI 20884521085975 Lots D2B2878RY D2E2680RY D2E2769RY Model S-187 SOFSILK* 1 BLK 6X45CM PCT X36 UDI-DI 20884521085982 Lot D2A1585RY Model S-243 SOFSILK* 4-0 BLK 12X60CM PCT X36 UDI-DI 20884521086170 Lots D1M1020RY D2D2348RY D2E1492RY Model S-246 SOFSILK* 0 BLK 6X60CM PCT X36 UDI-DI 10884521086203 Lot D2E1375RY UDI-DI 20884521086200 Lots D2E1375RY D2E1488RY Model S-2780K SOFSILK* 6-0 BLK 45CM SS-24DA UDI-DI 20884521086408 Lot D2C1916RY Model S-282 SOFSILK* 5 BLK 3X60CM PCT X36 UDI-DI 20884521086453 Lot D2E1470RY Model S-303 SOFSILK* 4-0 BLK 12X75CM PCT X36 UDI-DI 20884521086460 Lots D2E1495RY D2E1496RY Model S-304 SOFSILK* 3-0 BLK 12X75CM PCT X36 UDI-DI 20884521086477 Lot D2E1472RY Model S-305 SOFSILK* 2-0 BLK 12X75CM PCT X36 UDI-DI 20884521086484 Lots D2C1479RY D2E2772RY Model S-318 SOFSILK* 2 BLK 12X75CM PCT X24 UDI-DI 20884521086538 Lots D1M0153RY D2A1677RY Model SS-1694G SOFSILK 4/0 BLK 45CM P24 X12 UDI-DI 20884521176406 Lot D1M0141FRY Model S-605 SOFSILK* 2-0 BLK 2X150CM PCT X36 UDI-DI 20884521086620 Lot D2E1491RY Model S-608 SOFSILK* 2 BLK 2X150CM PCT X36 UDI-DI 20884521086668 Lots D1M0173RY D1M0635RY D2E1210RY Model VS872 SOFSILK* 3-0 BLK 75CM CV23 X36 UDI-DI 20884521090184 Lot D1M1837RY Model VS872-2 SOFSILK 3-0 30 BK CV-23 VS872-2 UDI-DI 20884521758060 Lot D2B1783RY Model SS-5641 SOFSILK* 4-0 BLK 45CM P13 X36 UDI-DI 20884521086774 Lot D2B2181FRY Model SS-5649G SOFSILK* 6-0 BLK 45CM P13 X12 UDI-DI 20884521086804 Lot D2C1987FRY Model SS-645 SOFSILK* 4-0 BLK 75CM C12 X36 UDI-DI 20884521087580 Lot D1M2531FRY Model SS-675 SOFSILK* 3-0 BLK 75CM C16 X36 UDI-DI 20884521087726 Lot D1K1916FRY Model SS-681 SOFSILK* 6-0 BLK 45CM C12 X36 UDI-DI 20884521087924 Lot D2G0795FRY Model VS-872 SOFSILK* 3-0 BLK 75CM CV23 X36 UDI-DI 20884521090184 Lot D1M1837RY Model XX-5280 SOFSILK* 0 BLK 150CM PCT X36 UDI-DI 20884521106045 Lot D2E1482RY -- Ti-Cron Coated Braided Polyester Sutures: 3087-31 TICRON* 4-0 BLU 75CM CV-331DA UDI-DI 10884521632271 Lot D1M2840RY 3226-31 TICRON* 4-0 BLU 60CM CV330 DA UDI-DI 10884521632547 Lot D2G1007RY 88863026-71 TICRON* 1 BLU 75CM HOS12X36 UDI-DI 20884521059129 Lot D2C1802RY 88863070-51 TICRON* 2-0 BLU 75CM C15X36 UDI-DI 20884521059570 Lot D2C3250FRY 88863087-31 TICRON* 4-0 BLU 75CM CV33DA UDI-DI 10884521059832 Lot D1M2840RY 88863092-71 TICRON* 1 BLU 75CM KV37X36 UDI-DI 20884521059990 Lot D2C2450RY 88863147-83 TICRON 2 BLU 5X75CM KV37X12 UDI-DI 10884521060340 Lot D1K0110RY 88863185-41 TICRON* 3-0 BLU 75CM CV305 UDI-DI 20884521061191 Lot D2C0774RY 88863186-31 TICRON* 4-0 BLU 75CM CV331 UDI-DI 10884521061279 Lot D2G1004RY UDI-DI 20884521061276 Lot D2G1004RY 88863226-31 TICRON* 4-0 BLU 60CM CV330DA UDI-DI 20884521061634 Lot D2G1007RY 88863226-41 TICRON* 3-0 BLU 60CM CV330DA UDI-DI 20884521061641 Lot D2A0451RY 88863229-31 TICRON* 4-0 BLU 75CM CV307DA UDI-DI 20884521061689 Lot D2G1307RY 88863271-31 TICRON* 4-0 BLU 90CM CV331DA UDI-DI 10884521062177 Lot D2F2152RY UDI-DI 20884521062174 Lot D2F2152RY 88863309-71 TICRON* 1 BLU 75CM GS11X36 UDI-DI 20884521062488 Lot D2D2188RY -- Monosof Monofilament Nylon Sutures: N-63 MONOSOF* 3-0 BLK 12X45CM PCT X36 UDI-DI 20884521076607 Lot D2A0862RY SN-3695 MONOSOF* 5-0 BLK 45CM P10 X12 UDI-DI 20884521077994 Lot D2C1333FRY D2H1541FRY -- Steel Monofilament Stainless Steel Sutures 88862224-49 STEEL 7 4X45CM SCC X12 UDI-DI 20884521102351 Lot D3B1366RY
Recalling Firm/
Manufacturer		 Covidien LP
15 Hampshire St
Mansfield MA 02048-1113
For Additional Information Contact Technical Service
800-962-9888 Ext. 2
Manufacturer Reason
for Recall		 Specific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
FDA Determined
Cause 2		 Process control
Action On December 21, the firm notified affected consignees via URGENT MEDICAL DEVICE RECALL letters. Customers were instructed to identify, quarantine, and return all unused, non-expired affected sutures to Medtronic. Please contact rs.covidienfeedbackcustomerservice@medtronic.com for the Return Good Authorization (RGA). Customers will receive credit for returned affected product. If purchased from a distributor, please contact your distributor directly to arrange for the return of product back to your distributor. Pass on the recall notice to all those who need to be aware within your organization, or to any organization where the affected sutures have been transferred or distributed. If you have questions regarding this recall, please call Medtronic Quality Assurance at 800-255-6774 option 1, then option 1 ***Updated 4/1/2024*** Firm identified additional models and lots affected by the gamma radiation issue and sent additional notification to customers on January 25, 2024.
Quantity in Commerce 46,812 US; 68,976 OUS
Distribution Worldwide US Nationwide distribution including in the states of AL, AZ, CA, FL, GA, HI, IA, IL, IN, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, VA, WA, WV and the countries of Australia, Bahrain, Belgium, Bulgaria, Canary Islands, China, Cyprus, Czech Republic, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Republic Of Kosovo, Mongolia, Netherlands, New Zealand, Panama, Poland, Portugal, Puerto Rico, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GAP and Original Applicant = UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
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