FDA Medical Device Recalls (openFDA)
Medtronic: 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
- Recall number
- Z-2543-2017
- Recalling firm
- Medtronic
- 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
- Status
- Terminated
- Initiated
- 2017-05-03
- Posted
- not on file
- Terminated
- 2019-07-18
- Reason
- Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
- Root cause
- Process control
- Action
- All consignees were notified via Federal Express or certified mail on May 3, 2017, and the letter informs customers of the potential for an incomplete seal on the inner package and the actions they should take. Customers are requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice.
- Quantity
- 478,465 (total for all products)
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K934738"]
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 1219930
- Firm city
- North Haven
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28