Recall Z-0487-2025— ETHICON, INC.
Class II · Ongoing
Class II FDA medical device recall by ETHICON, INC., initiated 2024-10-08. It names one FDA 510(k) clearance: K964072. 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: Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length..
- Recalling firm
- ETHICON, INC.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-08
- Firm location
- Juarez, N/A, Mexico
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Data sourced from openFDA. This site is unofficial and independent of the FDA.