Embrace Drill Tower, Standard/Lateral (25mm)
Class I - DangerousWhat Should You Do?
- Check if you have this product: Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
- 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:
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Reason for Recall:
- The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Embrace Drill Tower, Standard/Lateral (25mm)
Product Codes/Lot Numbers:
Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1258-2024
Related Recalls
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
Waldemar Link GmbH & Co. KG (Mfg Site)
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
LinkSymphoKnee System, Tibial Component, Modular, Symmetric, Sz. 5, CoCrMo/TiNbN, cemented, Fixed. REF Number: 880-100/50
Waldemar Link GmbH & Co. KG (Mfg Site)
Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.
Waldemar Link GmbH & Co. KG (Mfg Site)
Inconsistent size terminology and color coding used on labeling