Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Capio SLIM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Capio SLIM see related information
Date Initiated by Firm February 12, 2018
Date Posted May 04, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall Number Z-1617-2018
Recall Event ID 79608
510(K)Number K172060  
Product Classification Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Product Capio SLIM Box 5, Model #M0068318261;

Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Code Information UDI:08714729842224. Batch numbers:  19083076 19490462 20703048 19138102 19575737 20703101 19138104 19579790 20706387 20552143 19583816 20779052 20552145 19588973 20786955 20552147 19604718 20838609 20552300 19715051 20838611 19138106 19720437 20838613 19138108 19730190 20838615 19334997 19760389 20838617 20552153 19818985 20838619 17685429 19825371 20838661 17689642 19868166 20838663 17774102 19868170 20838665 17777555 19873851 20838667 17792395 19873853 20838670 17899922 19945906 20902946 17906429 19950376 20908772 17907124 19965002 20908774 17907855 19998515 20908776 17915689 20000798 20908778 17919851 20001166 20923178 17920787 20005049 20933960 17985873 20061149 20933962 17990901 20061151 20968696 17995421 20061153 20971515 17997519 20061155 20978294 18001945 20078729 21058901 18005330 20079183 21135392 18024683 20179283 21149060 18036357 20179505 21153916 18104991 20183190 21153918 18111726 20183193 21238940 18115409 20189154 21240810 18120488 20196783 21244374 18212832 20260976 21244755 18217456 20275824 21246277 18221332 20300581 21246370 18222053 20300685 21277765 18295603 20300689 21278301 18299439 20300692 21347579 18388438 20305782 21347701 18394085 20331414 21358289 18396171 20331416 21360859 18399797 20331418 21366235 18410457 20355333 21386338 18414187 20359462 21386740 18498497 20359470 21402640 18500136 20360846 21408533 18513753 20367015 21408536 18517656 20416925 21412229 18518037 20417300 20633990 18626569 20417302 20633992 18642959 20417304 20637803 18645072 20436291 20637805 18648870 20440668 20638061 18673869 20440672 20701932 18737139 20440674 19334999 18795870 20440677 19335461 18849259 20440679 19418628 18852877 20473754 19418630 18915563 20473758 19437992 18921359 20484087 19482938 18929303 20488264 20554655 18938181 20532138 20580835 19027577 20532440 20582262 19027750 20533045 19243606 19027752 20533047 19243608 19027754 20533580  19079309 20533582     
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Nicole Pshon
763-494-1133
Manufacturer Reason
for Recall		 Potential for Capio sutures to break and /or detach.
FDA Determined
Cause 2		 Device Design
Action Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative. **No product is being recalled and you are not required to return product to Boston Scientific** There is no impact to previously implanted mesh devices.
Quantity in Commerce 60,538
Distribution Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.
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 = PWI and Original Applicant = Boston Scientific Corporation
-
-