LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A
- 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:
- Encore Medical, Lp
- Reason for Recall:
- Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.
Product Codes/Lot Numbers:
1005528A, 1006882A, 1107305A, 1101798A, 1100565A, 1005531A, 1211716A, 1007408A, 1004038B, 1005533D, 1106805A, 1203471A, 1005533C, 1100565A, 1101795A, 1007079A, 1005532A, 1100560A
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1191-2017
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