TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Class I - DangerousWhat Should You Do?
- Check if you have this product: P239175
- 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:
- Medtronic Sofamor Danek USA Inc
- Reason for Recall:
- The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Product Codes/Lot Numbers:
P239175
Distribution:
Distributed in: AR, MN, MA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2638-2016
Related Recalls
Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix
Medtronic Sofamor Danek USA
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Grafton DMB Matrix, Model Numbers: a) T42200, b) T42210; Demineralized Bone Matrix
Medtronic Sofamor Danek USA
Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.