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
This recall has been terminated (originally issued May 3, 2017).
- Company
- Medtronic
- Recall Initiated
- May 3, 2017
- Terminated
- July 18, 2019
- Recall Number
- Z-2543-2017
- Quantity
- 478,465 (total for all products)
- Firm Location
- North Haven, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
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 / Code Info
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
Root Cause
Process control
Action Taken
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.