Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111; POLYSORB 0 18 UNDYED PRECUT, Item Number: L24; POLYSORB 0 18" UNDYED GS-21 DT, Item Number: CL14MG; POLYSORB 0 18" VIOLET PRECUT, Item Number: L27; POLYSORB 0 60 U/D REEL 203G, Item Number: LL104; POLYSORB 1 18" UNDYED PRECUT, Item Number: L25; POLYSORB 1 18" VIOLET GS-21 DT, Item Number: CL11MG; POLYSORB 1 30" VIOLET GS-21 DT, Item Number: CL6M; POLYSORB 1 30" VIOLET GS-22 DT, Item Number: CL885M; POLYSORB 1 30" VIOLET GS-25 DT, Item Number: CL64M; POLYSORB 2 VL 5 X 30" BGST-29 DT, Item Number: CLT633M; POLYSORB 2/0 18" UNDYED GS-10 DT, Item Number: CL52MG; POLYSORB 2/0 18" UNDYED GS-21 DT, Item Number: CL13MG; POLYSORB 2/0 18" VIOLET V-20 DT, Item Number: GL62MG; POLYSORB 2/0 30" VIOLET V-20 DT, Item Number: GL66M; POLYSORB 2-0 30" VIOLET V-30 DT, Item Number: GL223M; POLYSORB 3/0 18" UNDYED V-20 DT, Item Number: GL69MG; POLYSORB 3/0 18" VIOLET CV-25 DT, Item Number: GL33MG and GLJ50M; POLYSORB 3/0 18" VIOLET V-20 DT, Item Number: GL63MG; POLYSORB 3/0 30" VIOLET V-20 DT, Item Number: GL67M; POLYSORB 3/0 60 U/D REEL 104R, Item Number: LL102; POLYSORB 3-0 30" VIOLET CV-25 DT, Item Number: GL182M; POLYSORB 4/0 18" VIOLET CV-25 DT, Item Number: GL34MG; POLYSORB 4/0 30" VIOLET V-20 DT, Item Number: GL68M; POLYSORB* 0 18" VIOLET GS-21 DT, Item Number: CL10MG; POLYSORB* 0 24" VIOLET PRECUT, Item Number: L34; POLYSORB* 0 30" VIOLET GS-21 REG ATTCH, Item Number: 3CL812; POLYSORB* 0 30" VIOLET GS-22 DT, Item Number: CL886M; POLYSORB* 0 30" VIOLET PRECUT, Item Number: L40; POLYSORB* 0 5 X 30" UNDYED GS-21 DT, Item Number: CL2M; POLYSORB* 0 VIOLET 5X30" HGS-20 D-TACH, Item Number: CL997MG; POLYSORB* 0 VIOLET 5X30" HGS-21 D-TACH, Item Number: CL71M; POLYSORB* 0 VIOLET 60 REEL, Item Number: LL114; POLYSORB* 0 VIOLET 98" REEL, Item Number: LL224; POLYSORB* 1 18" VIOLET PRE-CUT, Item Number: L35; POLYSORB* 1 30" VIOLET PRECUT, Item Number: L41; POLYSORB* 1 5 X 30" VIOLET HOS-12 DT, Item Number: CL97MG; POLYSORB* 1 VIOLET 30" GS-26, Item Number: CL60M; POLYSORB* 1 VIOLET 98" REEL, Item Number: LL225; POLYSORB* 2 30" VIOLET GS-25 DT, Item Number: CL665M; POLYSORB* 2 UNDYED 12X18" PRECUT, Item Number: L26; POLYSORB* 2 VIOLET 12X18" PRECUT, Item Number: L28; POLYSORB* 2 VIOLET 2X36" BGS-29 (2X90CM), Item Number: 2CL852; POLYSORB* 2 VIOLET 30" GS-26, Item Number: CL659M; POLYSORB* 2 VIOLET 5X24" GS-24 D-TACH*, Item Number: CL622M; POLYSORB* 2 VIOLET 6X30" PRE-CUT, Item Number: L42; POLYSORB* 2 VIOLET 98" REEL, Item Number: LL226; POLYSORB* 2-0 VIOLET 60 REEL, Item Number: LL113; POLYSORB* 2-0 VIOLET 98" REEL, Item Number: LL223; POLYSORB* 3-0 VIOLET 60 REEL, Item Number: LL112; POLYSORB* 3-0 VIOLET 98" REEL, Item Number: LL222; POLYSORB* 4/0 98" VIOLET REEL 110T, Item Number: LL221
FDA Recall Z-2541-2017 · Posted None
Recalling FirmMedtronic
Recall StatusTerminated
Product CodeGAM
Date Initiated2017-05-03
Date Terminated2019-07-18
Product Quantity478,465 (total for all products)
Reason for Recall
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Firm Action
All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.
Root Cause
Process control
Distribution Pattern
Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.