DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Class I - DangerousWhat Should You Do?
- Check if you have this product: Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
- 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, Inc.
- Reason for Recall:
- Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Product Codes/Lot Numbers:
Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
Distribution:
Distributed in: US, PA, NC, TN, NY, WI, WA, MI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0092-2015
Related Recalls
One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.
There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.