Z-2543-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 21, 2017
- Initiation Date
- May 3, 2017
- Termination Date
- July 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 478,465 (total for all products)
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.
Distribution Pattern
Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
Code Information
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