PFR Kit- Pinnacle — Class II medical device recall Z-1624-2018
Terminated recall by Boston Scientific Corporation, reported 2018-05-16, distributed in GA.
| Recall number | Z-1624-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2018-02-12 |
| Classified | 2018-05-04 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2020-04-10 |
| Distributed | GA |
| Countries outside the US | AE, AR, AT, AU, BE, BH, BR, CA, CH, CL, CO, CR, CZ, DE, DK, DO, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, IE, IL, IR, IS, IT, JO, JP, KE, KW, LB, MT, MX, MY, NI, NL, NO, NZ, OM, PA, PE, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TR, TT, TW, VE, ZA |
| Quantity | 34 |
| UPC / GTIN / UDI-DI | 08714729773047 |
| Lot numbers | ML00002841 |
| Model numbers | M0068317100 |
Product
PFR Kit- Pinnacle, Anterior Apical; Model #M0068317100. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Reason for recall
Not stated by FDA.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1624-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.