iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number 0424647
- 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:
- Conformis, Inc.
- Reason for Recall:
- The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
Product Codes/Lot Numbers:
Serial Number 0424647
Distribution:
Distributed in: US, TN
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0731-2019
Related Recalls
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
30mm screws were labeled as 25mm screws.