Events

Recall of Device Recall Polysorb

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77144
  • Event Risk Class
    Class 2
  • Event Number
    Z-2541-2017
  • Event Initiated Date
    2017-05-03
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155023
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
  • Reason
    Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
  • 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.

Device

Device Recall Polysorb
  • Model / Serial
    POLSORB 0 18 U/D PRECUT 126R D4K0211X D4L1163X D5A0876X POLSORB 0 18 VIO PRECUT 226T D4L1165X D5A0247X D5A0248X D5A0546X POLSORB 0 30 VIO PRECUT 227C D4L1545X D5A0757X POLSORB 1 18 VIO PRECUT 122J D4L1161X D5A0096X POLSORB 1 30 VIO PRECUT 224E D5A0875X POLSORB 4/0 60"REEL VIO 217T D4L1509X POLYSORB 0 18 UNDYED PRECUT D4L1164X POLYSORB 0 18" UNDYED GS-21 DT D4L1756X D4L1758X D5A1745X POLYSORB 0 18" VIOLET PRECUT D5A0249X D5A0755X D5A1219X D5A1220X D5A1315X POLYSORB 0 60 U/D REEL 203G D4K1537X D5A1294X POLYSORB 1 18" UNDYED PRECUT D5A0551X POLYSORB 1 18" VIOLET GS-21 DT D4J0442X D4K2262X D4M0073X D5B0260X D5B0263X POLYSORB 1 30" VIOLET GS-21 DT D4L1431X POLYSORB 1 30" VIOLET GS-22 DT D4J0841X D4K0619X D4L0147X D4L0427X D4M0370X POLYSORB 1 30" VIOLET GS-25 DT D4J1987X POLYSORB 2 VL 5 X 30" BGST-29 DT D4K2021X POLYSORB 2/0 18" UNDYED GS-10 DT D4K2361X D4M0071X D5A1862X POLYSORB 2/0 18" UNDYED GS-21 DT D4L1968X D5A0070X D5A0071X D5A0072X D5A1034X D5A1035X D5B0193X POLYSORB 2/0 18" VIOLET V-20 DT D4L1180GX D5A0308GX D5A0528GX D5A1042GX D5B0427GX POLYSORB 2/0 30" VIOLET V-20 DT D4K1263GX POLYSORB 2-0 30" VIOLET V-30 DT D4L1371X POLYSORB 3/0 18" UNDYED V-20 DT D5A0171GX D5A0409GX D5A0962GX D5A1748GX D5A1805GX D5A1869GX D5B0242GX D5B0267GX D5B0539GX D5B0540GX POLYSORB 3/0 18" VIOLET CV-25 DT D4L0058X D4L0108X D4L0637X D4L0638X D4L0639X D4L2006X D4L2010X D4L2201X D4M0267X D4M0362X D5A0170X D5A0172X D5A0307X D5A0479X D5A0529X D5A0963X D5A1041X D5A1401X D5A1422X D5B0149X D5B0266X D5B0844X POLYSORB 3/0 18" VIOLET V-20 DT D4L1177GX D4L1179GX D4L1962GX D4L2077GX D4L2202GX D5A0306GX D5A0480GX D5A1039GX POLYSORB 3/0 30" VIOLET V-20 DT D5A0513GX D5A0515GX POLYSORB 3/0 60 U/D REEL 104R D5A1291X POLYSORB 3-0 30" VIOLET CV-25 DT D4K2438X POLYSORB 4/0 18" VIOLET CV-25 DT D5A0410X D5A1037X D5A1397X D5A1398X D5A1399X D5A1400X D5A1746X D5A1747X D5A1870X D5B0148X D5B0150X D5B0243X D5B0536X POLYSORB 4/0 30" VIOLET V-20 DT D4L0759GX POLYSORB* 0 18" VIOLET GS-21 DT D5A0169X D5A0303X D5A0304X D5A0305X D5A0406X D5A0478X D5A0524X D5A0525X D5A0526X D5A0889X D5A0890X D5A0961X D5A1031X D5A1032X D5A1033X D5A1392X D5A1393X D5A1394X D5A1395X D5A1396X D5A1743X D5A1861X D5B0014X D5B0261X D5B0264X D5B0423X D5B0424X POLYSORB* 0 24" VIOLET PRECUT D4K2023X D4L1547X POLYSORB* 0 30" VIOLET GS-21 REG ATTCH D5A1024X POLYSORB* 0 30" VIOLET GS-22 DT D4K1616X POLYSORB* 0 30" VIOLET PRECUT D4M1190X D5A0228X D5A0549X POLYSORB* 0 5 X 30" UNDYED GS-21 DT D4K1415X D5A1026X D5A1028X POLYSORB* 0 VIOLET 5X30" HGS-20 D-TACH D4L1563X D4M1020X POLYSORB* 0 VIOLET 5X30" HGS-21 D-TACH D4M0368X POLYSORB* 0 VIOLET 60 REEL D4L1866X D5A0869X POLYSORB* 0 VIOLET 98" REEL D4L0689X D4L1166X D4L1677X D4L1867X D4L2107X D4M1187X D5A0723X D5A0724X D5A1298X POLYSORB* 1 18" VIOLET PRE-CUT D4K1272X D4L1740X D4M1189X D4M1224X D5A0756X POLYSORB* 1 30" VIOLET PRECUT D4K2024X D4L1162X D5A0548X POLYSORB* 1 5 X 30" VIOLET HOS-12 DT D4L1159X POLYSORB* 1 VIOLET 30" GS-26 D4L1131X POLYSORB* 1 VIOLET 98" REEL D4J0947X D4L0704X D4L2029X D4L2109X D5A0823X D5A0951X POLYSORB* 2 30" VIOLET GS-25 DT D4K1044X POLYSORB* 2 UNDYED 12X18" PRECUT D4J0736X D4K0212X D5A0402X POLYSORB* 2 VIOLET 12X18" PRECUT  D4K2022X D4L1546X POLYSORB* 2 VIOLET 2X36" BGS-29 (2X90CM) D4L0467X POLYSORB* 2 VIOLET 30" GS-26 D4M0542X POLYSORB* 2 VIOLET 5X24" GS-24 D-TACH* ( D4L0692X POLYSORB* 2 VIOLET 6X30" PRE-CUT D5A0098X POLYSORB* 2 VIOLET 98" REEL D4L0640X D4L0641X D4L0642X POLYSORB* 2-0 VIOLET 60 REEL D4L0065X D4L0515X D4L1429X D4L2118X D4M0410X D5A0104X D5A0109X POLYSORB* 2-0 VIOLET 98" REEL D4K1392X D4K1612X D4K2139X D4L0279X D4L0822X D4L1005X D4L1399X D4L2111X D4M1186X D5A0102X D5A0105X D5A0106X D5A0107X D5A0112X D5A0113X D5A1233X D5A1290X D5A1339X D5B0302X POLYSORB* 3-0 VIOLET 60 REEL D4L1170X D4L2106X D5A0110X D5A0771X D5A0811X POLYSORB* 3-0 VIOLET 98" REEL D4K2315X D5A1231X D5A1803X POLYSORB* 4/0 98" VIOLET REEL 110T  D4L1169X D4M0237X D5A1288X D5A1297X
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
  • Product Description
    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
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Address
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA