Recall Z-1625-2018— Boston Scientific Corporation

Name: FDA recall Z-1625-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-12

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2018-02-12, terminated 2020-04-10. It names one FDA 510(k) clearance: K071957. Product: PFR Kit- Pinnacle, Posterior; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.. Reason: Potential for Capio sutures to break and /or detach..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2018-02-12
Terminated: 2020-04-10
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K071957 — PINNACLE PELVIC FLOOR REPAIR KITSBoston Scientific Corp·cleared 2007-11-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Potential for Capio sutures to break and /or detach.

Data sourced from openFDA. This site is unofficial and independent of the FDA.