Z-1623-2018Class II

Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic...

Name: Z-1623-2018 Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic...
Creator: Boston Scientific Corporation
Published: 2018-02-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2018-02-12 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse on 2018-02-12. FDA classified it as Class II and gives the reason as "Potential for Capio sutures to break and /or detach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1623-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-12
Posted: 2018-05-04
Terminated: 2020-04-10
Recalling firm: Boston Scientific Corporation
Product: Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in women with pelvic organ prolapse.
Product code: PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Reason for recall: Potential for Capio sutures to break and /or detach.
Root cause tag: design
FDA root cause: Device Design
Action: Boston Scientific sent Urgent Medical Device Correction letters, dated February 12, 2018, to customers via FED-EX two day delivery. Customers were informed of the updates to the affected product instructions for use and advised to read the notification carefully and immediately post the information in a visible location near the product to ensure it is easily accessible to all users of the device. Also, the notification should be passed on to any health professional of the customer's organization that needs to be aware and to any organization where the potentially affected devices have been transferred. Customers with questions should contact their local BSC (Boston Scientific) Representative. **No product is being recalled and you are not required to return product to Boston Scientific** There is no impact to previously implanted mesh devices.
Quantity in commerce: 1,541
Distribution: Worldwide Distribution -- US, Brazil, Guatemala, Ecuador, Malaysia, Czech Republic, United Kingdom, Argentina, Honduras, Peru, Singapore, Denmark, Iceland, Chile, Nicaragua, Venezuela, Japan, Egypt, Israel, Canada, Panama, Taiwan, United Arab Emirates, Finland, Ireland, Mexico, Dominican Republic, Hong Kong, Austria, France, Italy, Costa Rica, Trinidad and Tobago, Australia, Bahrain, Georgia, Islamic Republic of Iran, El Salvador, Colombia, New Zealand, Belgium, Germany, Jordan, Norway, Russia, Pakistan, Slovakia, Portugal, South Africa, Oman, Saudi Arabia, Poland, Slovenia, Qatar, Spain, Kenya, Lebanon, Mauritius, Netherlands, Sweden, Turkey, Kuwait, Malta, Namibia, Romania, Switzerland, and Greece.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1623-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1616-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1617-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1618-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1619-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1620-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1621-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1622-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1623-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1624-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1625-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04
Z-1626-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-04

Product code PWI

K122459Class IIIPinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemBoston Scientific Corporation / cleared 2012-12-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)