Medtronic recalls Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU

Recalled June 21, 2017 · FDA recall Z-2543-2017 · Medtronic

Hazard

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

Units

478,465 (total for all products)

Sold at

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

Description

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

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

Manufacturer(s)

Medtronic

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →