Recall Z-1620-2018 ยท PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Boston Scientific Corporation
Capio Standard Box 4 (Capio PC); Model #M0068312321. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
| Date | May 4, 2018 (initiated Feb 12, 2018) |
| Status | Terminated |
| Reason | Potential for Capio sutures to break and /or detach. |
| Root cause | 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 |
| Quantity | 4,144 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932553 | DISPOSABLE SUTURE PLACEMENT SYSTEM Laurus Medical Corp., May 12, 1994 |