Recall Z-0487-2025 ยท GAN Suture, Absorbable, Synthetic
ETHICON, INC.
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.
| Date | Nov 19, 2024 (initiated Oct 8, 2024) |
| Status | Open, Classified |
| Reason | Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length. |
| Root cause | Process control |
| Action | On 10/08/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" Letter via UPS 2nd Day Air to customers informing them that due to a manufacturing component error/mix, Monocryl Suture, Product Code Y936H, Lot TMMCQD may contain some packages with incorrect needle type/size and suture diameter/length. Customers are instructed to: 1. Examine inventory immediately and quarantine such product(s). Maintain/keep a copy of this notice with the quarantined product and your records. 2. Communicate the issue to relevant personnel, or anyone else who needs to be informed. If any product has be |
| Quantity | 16,524 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964072 | MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED ETHICON, Inc., Dec 18, 1996 |