Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers 6602070, 6582333, 6581191, and 6581193
- 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:
- Synthes USA HQ, Inc.
- Reason for Recall:
- The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Product Codes/Lot Numbers:
Lot Numbers 6602070, 6582333, 6581191, and 6581193
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0941-2013
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