Device product
MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular and neurological tissues, microsurgery or ophthalmic surgery.
Z-0487-2025
Product summary
- Firm
- ETHICON, INC.
- Event
- Event 95583
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 16,524 devices
- Official record key
device-enforcement:Z-0487-2025
Official wording
Reason: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Code information: Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD
Distribution pattern: U.S.: AK, AL, AR, AZ, CA, CO,CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. O.U.S.: Not provided.
Derived failure modes
-
Unknown
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.