Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
Reported: June 10, 2015 Initiated: April 29, 2015 #Z-1694-2015
Product Description
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
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.
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 289,616
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada, Brazil, Mexico, Bahamas, Nicaragua, Singapore, China, Japan, Malaysia, Taiwan, Thailand, Korea, Spain, Belgium, Switzerland, India, Germany, England, Italy, Saudi Arabia, Lebanon, Libya, United Arab Emirates, Algeria, France, United Kingdom, Canary Islands, Iraq, Jordan, Lithuania, Morocco, Macedonia, Malta, Mauritius, Serbia, Russian Federation, and Yemen.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.. Recalled by Zimmer, Inc.. Units affected: 289,616.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2015. Severity: Moderate. Recall number: Z-1694-2015.
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