Z1 Femoral Hip System, Product Number 611777612
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277
- 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.
ā ļø Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer, Inc.
- Reason for Recall:
- There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Z1 Femoral Hip System, Product Number 611777612
Product Codes/Lot Numbers:
UDI-DI: 00887868577888; Lot Numbers: 102646 102777 102778 104095 104324 105277
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1329-2025
Related Recalls
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-EĀæ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.