Recall Z-2543-2017 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
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
| Date | May 3, 2017 |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934738 | AUTOSUTURE ENDOSCOPIC SUTURING DEVICE United States Surgical, A Division of Tyco Healthc, Mar 16, 1994 |