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U.S. Department of Health and Human Services

Class 2 Device Recall PFR Kit Pinnacle

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  Class 2 Device Recall PFR Kit Pinnacle 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-1625-2018
Recall Event ID 79608
510(K)Number K071957  
Product Classification Instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic organ prolapse - Product Code PWI
Product PFR Kit- Pinnacle, Posterior; Model #M0068317100.

Indicated for tissue reinforcement in women with pelvic organ prolapse.
Code Information GTIN: 08714729784449. Batch number:  ML00002919
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 24
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 CORP.
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