FDA recall Z-1616-2018

Product

Capio SLIM Suture Capturing Device, Model #M0068318250. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.

Reason for recall

Potential for Capio sutures to break and /or detach.

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.

Key facts

Status

Terminated

Initiation date

2018-02-12

Report date

2018-05-16

Termination date

2020-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1616-2018