Z-2543-2017Class II

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

Name: Z-2543-2017 Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48"...
Creator: Medtronic
Published: 2017-05-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-05-03 / Terminated / root cause: manufacturing process

FDA source

Medtronic began a recall of 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... on 2017-05-03. FDA classified it as Class II and gives the reason as "Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2543-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-03
Posted: 2017-06-14
Terminated: 2019-07-18
Recalling firm: Medtronic, Inc.
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
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2543-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2541-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2542-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2543-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2544-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2545-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2546-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2547-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14
Z-2548-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-21	2017-06-14

Product code GAM

K934738Class IIAutosuture Endoscopic Suturing DeviceUnited States Surgical, A Division of Tyco Healthc / cleared 1994-03-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)