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Recall Observatory FDA recall evidence

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

October 08, 2024

Class II

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

    reason.no_named_rule · v1.0.0

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