Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
- 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:
- Integra Limited
- Reason for Recall:
- As a result of complaint investigations it was identified that there is a potential that the Leyla Ball Joint Clamp (R2383) may not provide the level of stability needed to maintain retraction in all cases.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Integra Leyla Ball Joint Clamp, also as included in Leyla Table Mounting Hardware. The Leyla Retraction System, as part of the Ruggles brand of instruments is intended for use as a self-retaining retractor which is a self-locking device used to hold the edges of a wound open during neurosurgery.
Product Codes/Lot Numbers:
Catalog Number R2383 and as a component of catalog number R2385, including all lot numbers date codes going back to January 2006.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2056-2013
Related Recalls
Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110¿F