FDA recall Z-2543-2017

Medtronic · Class II · device

Product

Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053

Reason for recall

Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.

Distribution

Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.

Key facts

Status: Terminated
Initiation date: 2017-05-03
Report date: 2017-06-21
Termination date: 2019-07-18
Voluntary/Mandated: Voluntary: Firm initiated
Location: North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2017