Device recall
ETHILON Nylon Suture, Product Code 697G
- Recall number
- Z-0284-2027
- Event id
- 99947
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Ethicon, LLC
- Report date
- Nov 4, 2026
- Posted
- Oct 23, 2026
- Initiated
- Sep 23, 2026
- Center classification date
- Oct 23, 2026
- Product code
- GAQ
- Device type
- Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
- Reason
- Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.
- Root cause
- Process control
- Quantity
- 4,003
- Code info
- GTIN Box/Unit: 30705031008568/10705031008564. Lot: 10B3QS
- Distribution
- International distribution to the countries of JP, CA, AU.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K946173
- Location
- San Lorenzo, PR, United States