12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item# MDS9091212B; Lots #136780
- 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:
- MEDLINE INDUSTRIES INC
- Reason for Recall:
- Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.
Product Codes/Lot Numbers:
Item# MDS9091212B; Lots #136780
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2107-2017
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