AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Number: 964W1000
- 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:
- Encore Medical, LP
- Reason for Recall:
- Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.
Product Codes/Lot Numbers:
Lot Number: 964W1000
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0117-2021
Related Recalls
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.