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
Z-2543-2017
Product summary
- Firm
- Medtronic
- Event
- Event 77144
- Status
- Terminated
- Classification
- Class II
- Quantity
- 478,465 (total for all products)
- Official record key
device-enforcement:Z-2543-2017
Official wording
Reason: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Code information: ENDO STITCH* POLYSORB* 0 48" U/D DLU SU J4M0853X J4M0855X J5A0192X ENDO STITCH* POLYSORB* 0 48" VIO DLU SU J4L1477X ENDO STITCH*POLYSORB* 2/0 48" U/D DLU SU J5A1097X ENDO STITCH*POLYSORB* 2/0 48" VIO DLU SU J5A0702X J5A0703X J5A0704X J5A0705X J5A1206X J5A1207X
Distribution pattern: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
Derived failure modes
-
Labeling or packaging
incomplete seal