SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Class I - DangerousWhat Should You Do?
- Check if you have this product: SYNTHECEL Dura Repair 2.5 cm x 7.5 cm (1x3), part numbers: SC.400.019.01S, Lot Numbers: 7840492, 7855337, 7860565, 7880949, 7901437, 7909570, 7922341
- 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) Products LLC
- Reason for Recall:
- It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.
Product Codes/Lot Numbers:
SYNTHECEL Dura Repair 2.5 cm x 7.5 cm (1x3), part numbers: SC.400.019.01S, Lot Numbers: 7840492, 7855337, 7860565, 7880949, 7901437, 7909570, 7922341
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1384-2016
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