iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Class I - DangerousWhat Should You Do?
- Check if you have this product: 0448088
- 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:
- Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
- 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, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Product Codes/Lot Numbers:
0448088
Distribution:
Distributed in: MD, NV
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0063-2020
Related Recalls
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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.