FDA recall Z-0487-2025

ETHICON, INC. · Class II · 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.

Reason for recall

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2024-10-08
Report date
2024-11-27
Voluntary/Mandated
Voluntary: Firm initiated
Location
Juarez, N/A, Mexico

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0487-2025