Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots. Part numbers: 00-2253-020-45 INTERLOCKING IM SCREW 4.5MM DIA X 20MM 00-2253-022-45 INTERLOCKING IM SCREW 4.5MM DIA X 22.5MM 00-2253-025-45 INTERLOCKING IM SCREW 4.5MM DIA X 25MM 00-2253-027-45 M/DN Intramedullary Fixation 4.5mm Dia. Cortical Screw 00-2253-030-45 INTERLOCKING IM SCREW 4.5MM DIA X 30MM 00-2253-032-45 INTERLOCKING IM SCREW 4.5MM DIA X 32.5MM 00-2253-035-45 INTERLOCKING IM SCREW 4.5MM DIA X 35MM 00-2253-037-45 INTERLOCKING IM SCREW 4.5MM DIA X 37.5MM 00-2253-040-45 INTERLOCKING IM SCREW 4.5MM DIA X 40MM 00-2253-042-45 INTERLOCKING IM SCREW 4.5MM DIA X 42.5MM 00-2253-045-45 INTERLOCKING IM SCREW 4.5MM DIA X 45MM 00-2253-047-45 INTERLOCKING IM SCREW 4.5MM DIA X 47.5MM 00-2253-050-45 INTERLOCKING IM SCREW 4.5MM DIA X 50MM 00-2253-052-45 INTERLOCKING IM SCREW 4.5MM DIA X 52.5MM 00-2253-055-45 INTERLOCKING IM SCREW 4.5MM DIA X 55MM 00-2253-057-45 INTERLOCKING IM SCREW 4.5MM DIA X 57.5MM 00-2253-060-45 INTERLOCKING IM SCREW 4.5MM DIA X 60MM 00-2253-062-45 INTERLOCKING IM SCREW 4.5MM DIA X 62.5MM 00-2253-065-45 INTERLOCKING IM SCREW 4.5MM DIA X 65MM 00-2253-067-45 INTERLOCKING IM SCREW 4.5MM DIA X 67.5MM 00-2253-070-45 INTERLOCKING IM SCREW 4.5MM DIA X 70MM 00-2253-072-45 INTERLOCKING IM SCREW 4.5MM DIA X 72.5MM 00-2253-075-45 INTERLOCKING IM SCREW 4.5MM DIA X 75MM 00-2253-077-45 INTERLOCKING IM SCREW 4.5MM DIA X 77.5MM 00-2253-080-45 INTERLOCKING IM SCREW 4.5MM DIA X 80MM 00-2253-082-45 INTERLOCKING IM SCREW 4.5MM DIA X 82.5MM 00-2253-085-45 INTERLOCKING IM SCREW 4.5MM DIA X 85MM 00-2253-087-45 INTERLOCKING IM SCREW 4.5MM DIA X 87.5MM 00-2253-090-45 INTERLOCKING IM SCREW 4.5MM DIA X 90MM
- 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:
- The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Product Codes/Lot Numbers:
All lots. Part numbers: 00-2253-020-45 INTERLOCKING IM SCREW 4.5MM DIA X 20MM 00-2253-022-45 INTERLOCKING IM SCREW 4.5MM DIA X 22.5MM 00-2253-025-45 INTERLOCKING IM SCREW 4.5MM DIA X 25MM 00-2253-027-45 M/DN Intramedullary Fixation 4.5mm Dia. Cortical Screw 00-2253-030-45 INTERLOCKING IM SCREW 4.5MM DIA X 30MM 00-2253-032-45 INTERLOCKING IM SCREW 4.5MM DIA X 32.5MM 00-2253-035-45 INTERLOCKING IM SCREW 4.5MM DIA X 35MM 00-2253-037-45 INTERLOCKING IM SCREW 4.5MM DIA X 37.5MM 00-2253-040-45 INTERLOCKING IM SCREW 4.5MM DIA X 40MM 00-2253-042-45 INTERLOCKING IM SCREW 4.5MM DIA X 42.5MM 00-2253-045-45 INTERLOCKING IM SCREW 4.5MM DIA X 45MM 00-2253-047-45 INTERLOCKING IM SCREW 4.5MM DIA X 47.5MM 00-2253-050-45 INTERLOCKING IM SCREW 4.5MM DIA X 50MM 00-2253-052-45 INTERLOCKING IM SCREW 4.5MM DIA X 52.5MM 00-2253-055-45 INTERLOCKING IM SCREW 4.5MM DIA X 55MM 00-2253-057-45 INTERLOCKING IM SCREW 4.5MM DIA X 57.5MM 00-2253-060-45 INTERLOCKING IM SCREW 4.5MM DIA X 60MM 00-2253-062-45 INTERLOCKING IM SCREW 4.5MM DIA X 62.5MM 00-2253-065-45 INTERLOCKING IM SCREW 4.5MM DIA X 65MM 00-2253-067-45 INTERLOCKING IM SCREW 4.5MM DIA X 67.5MM 00-2253-070-45 INTERLOCKING IM SCREW 4.5MM DIA X 70MM 00-2253-072-45 INTERLOCKING IM SCREW 4.5MM DIA X 72.5MM 00-2253-075-45 INTERLOCKING IM SCREW 4.5MM DIA X 75MM 00-2253-077-45 INTERLOCKING IM SCREW 4.5MM DIA X 77.5MM 00-2253-080-45 INTERLOCKING IM SCREW 4.5MM DIA X 80MM 00-2253-082-45 INTERLOCKING IM SCREW 4.5MM DIA X 82.5MM 00-2253-085-45 INTERLOCKING IM SCREW 4.5MM DIA X 85MM 00-2253-087-45 INTERLOCKING IM SCREW 4.5MM DIA X 87.5MM 00-2253-090-45 INTERLOCKING IM SCREW 4.5MM DIA X 90MM
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1694-2015
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.