FDA Device recall Z-1625-2018
PFR Kit- Pinnacle, Posterior
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of PFR Kit- Pinnacle, Posterior by Boston Scientific, citing potential for Capio sutures to break and /or detach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1625-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-12 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | GA |
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.
Identifiers
| code_info | GTIN: 08714729784449. Batch number: ML00002919 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1625-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.