Z-1625-2018Class II
PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic...
Boston Scientific Corporation / initiated 2018-02-12 / Terminated / root cause: design
Boston Scientific Corporation began a recall of PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse on . FDA classified it as Class II and gives the reason as "Potential for Capio sutures to break and /or detach". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1625-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Boston Scientific Corporation
- Product
- PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
- Product code
- PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
- Reason for recall
- Potential for Capio sutures to break and /or detach.
- Root cause tag
- design
- FDA 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 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.
- Product codes and lots
- GTIN: 08714729784449. Batch number: ML00002919
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1616-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1617-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1618-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1619-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1620-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1621-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1622-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1623-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1624-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1625-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1626-2018 | Class II | Terminated | Voluntary: Firm initiated |
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