Recall Z-2543-2017— Medtronic

Name: FDA recall Z-2543-2017
Creator: U.S. Food and Drug Administration
Published: 2017-05-03

Class II · Terminated

Class II FDA medical device recall by Medtronic, initiated 2017-05-03, terminated 2019-07-18. It names one FDA 510(k) clearance: K934738. 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: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material..

Recalling firm: Medtronic
Classification: Class II
Status: Terminated
Initiated: 2017-05-03
Terminated: 2019-07-18
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K934738 — AUTOSUTURE ENDOSCOPIC SUTURING DEVICEUnited States Surgical, A Division of Tyco Healthc·cleared 1994-03-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.