Boston Scientific Corporation: PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

Is my product affected?

PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.

• UPC 08714729784449

Check against the official notice below — it lists the full affected range.

What happened

Boston Scientific Corporation is recalling the PFR Kit-Pinnacle, Posterior (Model #M0068317100) used for tissue reinforcement in women with pelvic organ prolapse. The recall affects 24 units distributed worldwide across more than 40 countries including the United States, Canada, Australia, Japan, and numerous others in Europe, Latin America, and Asia. The product is being recalled due to a potential for Capio sutures to break and/or detach. The affected batch number is ML00002919.

The recall record does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for Capio sutures to break and /or detach.

Details from the source

Reason for recall: Potential for Capio sutures to break and /or detach. 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, Isla Quantity: 24 Lot/code info: GTIN: 08714729784449. Batch number: ML00002919

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

• Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.2018-02-12
• 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.2018-02-12
• Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.2018-02-12
• Capio Open Access Box 4 (Capio OPC); Model #M0068311251. 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.2018-02-12
• 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.2018-02-12

All FDA (Device enforcement) recalls