Boston Scientific recalls PFR Kit Pinnacle Posterior Model M0068317100 for potential sutures breaking, which could cause tissue reinforcement failure in pelvic organ prolapse treatment.
Potential for Capio sutures to break and /or detach.
Boston Scientific is recalling a specific surgical kit for pelvic organ prolapse repair. The kit may have sutures that break or detach, which could lead to treatment failure or complications.
The sutures in the kit could break or detach during use, which might cause the tissue reinforcement to fail. This could lead to complications in pelvic organ prolapse treatment.
Women who have received this specific surgical kit for pelvic organ prolapse repair are affected. Those with the model number M0068317100 are most at risk.
Check for the model number M0068317100 on the kit. The kit is intended for women with pelvic organ prolapse and has a batch number starting with ML00002919.
Look for the model number M0068317100 on the kit packaging or label.
The recall indicates a potential risk of sutures breaking or detaching, so it is not recommended for use without checking the recall.
The recall does not specify a remedy, so contact Boston Scientific directly for guidance.
Look for the model number M0068317100 and batch number starting with ML00002919 on the kit.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-1625-2018 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-1625-2018 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
