ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model 0234020280, UDI 07613154643264, Lot No. 17299AG2
- 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:
- Stryker Corporation
- Reason for Recall:
- Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates. It is indicated to be a single surgery use, disposable set of instrumentation for anterior cruciate ligament (ACL) reconstruction surgeries.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ACL DISPOSABLE PACK BONE-TENDON-BONE, Model 0234020280, labeled sterile.
Product Codes/Lot Numbers:
Model 0234020280, UDI 07613154643264, Lot No. 17299AG2
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0838-2018
Related Recalls
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable.
Due to nonconforming products being inadvertently distributed.
Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures.