MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approxi
Summary
The FDA issued a Class II for MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicate by ETHICON, INC.. Reason: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length..
Details
Source
Device Recall
External ID
Z-0487-2025
Action Date
2024-11-27
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Product Number: Y936H UDI-DI code: 10705031059917 Lot Number: TMMDQD
Quantity Affected: 16,524 devices
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-08
Company
Juarez, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 280 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ETHICON, INC. has 23 FDA actions in our database, including 15 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ETHICON, INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ETHICON, INC. have FDA actions?
ETHICON, INC. has 23 FDA actions in our database, including 15 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0487-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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