Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Part number 14-531593 Part number 14-531594 Catalog number Lot Number 14-531593 N23597 14-531594 N23599
- 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:
- Ebi, Llc
- Reason for Recall:
- A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments ( the Sleeves ) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Product Codes/Lot Numbers:
Part number 14-531593 Part number 14-531594 Catalog number Lot Number 14-531593 N23597 14-531594 N23599
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0874-2015
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