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U.S. Department of Health and Human Services

Class 2 Device Recall Parietex Composite Parastomal Mesh

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  Class 2 Device Recall Parietex Composite Parastomal Mesh see related information
Date Initiated by Firm October 05, 2018
Create Date November 14, 2018
Recall Status1 Terminated 3 on May 07, 2020
Recall Number Z-0461-2019
Recall Event ID 81417
510(K)Number K142908  K081126  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20)

Product Usage:
The PCOPM15 and PCOPM20 reorder codes are circular in shape, made from a three-dimensional monofilament polyester fabric with a two-dimensional monofilament polyester central band. One side of the design is completely covered with the hydrophilic film. On the opposite side, only the two-dimensional central band is coated with the absorbable hydrophilic film. The film extends 5 mm over the external edge of the reinforcement. The Parietex composite parastomal mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
Code Information Lots PNI0064 PNI0065 PNI0402 PNJ0496 PNJ0989 PNJ0990 PNK0641 PNL0037 PNL0039 PNL0631 POA0469X POA0963X POB0030X POB0797X POC0036X POC0726X POD0033X POD0036X POD1016X POE0149X POE0262X POE0727X POF0295X POF0298X POG0047X POH0069X POH0070X POI0260X POI0261X POI0489X POJ0418X POJ0880X POK0364X POK0366X POK0789X POK0790X POL0082X PPA0226X PPA0227X PPA0508X PPA0509X PPB0779X PPB0780X PPC0578X PPD0409X PPD0410X PPE0215X PPE0509X PPF0179X PPF0181X PPF0836X PPG0035X PPG0723X PPH0355X PPI0630X PPI0631X PPI1144X PPI1145X PPJ0234X PPJ0235X PPJ0698X PPK0523X PPK0524X PPL0082X PPL0353X PQA0483X PQC0100X PQC0102X PQD0395X PQD0397X PQE0187X PQE0802X PQG0391X PQG1150X PQG1152X PQH0608X PQH0610X PQI1246X PQI1248X PQJ0971X PQJ0973X PQK0314X PQK0316X PQL0150X PQL0479X PQL0481X PRA1193X PRA1195X PRA1655X PRA1657X PRA2444X PRA2446X PRB1650X PRB1652X PRB2015X PRB2017X PRC0392X PRC0394X PRC1062X PRC1064X PRD0248X PRD0250X PRD0547X PRD0549X PRD1170X PRD1172X PRE0479X PRE0481X PRE1319X PRF0408X PRF0410X PRG0382X PRG1020X PRG1022X PRH0323X PRH0325X PRI0530X PRI0531X PRI1166X PRI1168X PRI1409X PRI1411X PRJ0480X PRJ0482X PRK0758X PRK0760X PRK1140X PRK1142X PRL0129X PRL0131X PRL0528X PRL0530X PSA0833X PSA0835X PSA1207X PSA1209X PSB0936X PSB0938X PSC0186X PSC0188X PSD0420X PSD0422X PSE0906X PSE0908X PSF0217X PSF0219X PSG0778X PSG0780X RQA1121X PRG0380X 
Recalling Firm/
Covidien LLC
60 Middletown Ave
North Haven CT 06473-3908
Manufacturer Reason
for Recall
The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal hernia repair using the modified Sugarbaker repair technique. In these reports, product failure led to hernia recurrence requiring additional surgical treatment. Symptoms of hernia recurrence may include discomfort, localized pain-free or painful bulging, and possible changes in the overlying skin. Medtronic has received, worldwide, a total of ten reports of mesh failure following use of the product in the last five years. Patients who have received a Parietex" composite parastomal mesh for the treatment of a parastomal hernia should continue to receive ongoing monitoring by their healthcare providers for the recurrence of a parastomal hernia.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action On October 5, 2018, the firm notified its customers of the product issue via Urgent Medical Device Voluntary Removal. Required Actions: 1. Please quarantine and discontinue use of the affected item codes. 2. Complete the Product Return Form even if you do not have inventory. If no inventory, fax to 203-492-7719 or email FCAMITG@covidien.com. 3. If purchased directly from Medtronic, fax the return form to 800-895-6140 or email feedback.customerservice@covidien.com. Ship affected product with RGA# provided by customer service to: Medtronic Attn: Field Returns Department 195 McDermott Road North Haven, CT 06473 USA 4. If purchased from a distributor, contact distributor directly to arrange for return of product. Fax completed form to 203-492-7719 or email FCAMITG@covidien.com. If you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
Quantity in Commerce 7333
Distribution Worldwide distribution--US Nationwide
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTL and Original Applicant = SOFRADIM PRODUCTION