Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in total or hemi hip arthroplasty
Class I - DangerousWhat Should You Do?
- Check if you have this product: lot no.: 62154349 62263555 62270747 62315652 62389960 62212034 62270748 62389957 37107513 62154348 62212021 62270746 62299145 62389956 62299145N
- 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:
- Zimmer Manufacturing B.V.
- Reason for Recall:
- As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Product 15 consists of all product code JDI , and same usage: Item no: 805002802 ASTEL FEM HEAD +0X28MM DI 805002805 ASTEL FEM HEAD +10.5X28MM 805002803 ASTEL FEM HEAD +3.5X28MM 805002804 ASTEL FEM HEAD +7X28MM DI 805002801 ASTEL FEM HEAD -3.5X28MM Usage: For use in total or hemi hip arthroplasty
Product Codes/Lot Numbers:
lot no.: 62154349 62263555 62270747 62315652 62389960 62212034 62270748 62389957 37107513 62154348 62212021 62270746 62299145 62389956 62299145N
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1113-2016
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