FDA Device recall Z-1623-2018
Posterior LITE w/ Capio SLIM
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Posterior LITE w/ Capio SLIM 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-1623-2018 |
| 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
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Reason
Potential for Capio sutures to break and /or detach.
Identifiers
| code_info | GTIN: 08714729854548 Batch numbers: 36893 20721161 20867461 39699 20750829 20884690 47724 20750830 20884691 49915…GTIN: 08714729854548 Batch numbers: 36893 20721161 20867461 39699 20750829 20884690 47724 20750830 20884691 49915 20750831 20884692 49916 20774546 21021770 52597 20803727 21250250 56828 20803728 21320277 58771 20803729 21351865 60410 20807399 21359456 60770 20807700 ML00003061 62154 20807701 ML00003213 62509 20830041 ML00003329 20720887 20830060 ML00003360 20720888 20830202 20720889 20865779 |
|---|
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-1623-2018%22
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