TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
Class I - DangerousWhat Should You Do?
- Check if you have this product: Batch Numbers: 2013904 2018628 2023177 2025213 2039590 2050959 2052719
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smith & Nephew, Inc.
- Reason for Recall:
- Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
TWINFIX ULTRA HA 4.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Number: 72202624
Product Codes/Lot Numbers:
Batch Numbers: 2013904 2018628 2023177 2025213 2039590 2050959 2052719
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0162-2021
Related Recalls
META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Smith & Nephew
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
The Bipolar assembly contains an oversized Retainer Ring.