Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part number: AR-13200T-15.0; Lot code:12135408
- 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:
- Arthrex, Inc.
- Reason for Recall:
- It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Product Codes/Lot Numbers:
Part number: AR-13200T-15.0; Lot code:12135408
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1380-2021
Related Recalls
The devices may be packaged with the wrong reamer size.
K-Wire, 1.35 mm x 170 mm
Arthrex
Products do not meet length and diameter specifications.
Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.