Zimmer Recalls 4.5mm Cortical Screws for M/DN Intramedullary Nail System
Zimmer, Inc. is recalling 4.5mm Cortical Screws for the M/DN system because they are not compatible with the device, potentially causing surgical complications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that poses a risk of harm during or after surgery, but the source text does not report any specific injuries, hospitalizations, or deaths, fitting the criteria for a High severity rating.
Plain-English summary
Zimmer, Inc. is recalling 289,616 units of 4.5mm Cortical Screws intended for use with the Metaphyseal/Diaphyseal (M/DN) Intramedullary Nail System. The recall covers all lots of these specific part numbers, which were distributed worldwide, including in the United States and numerous international markets.
The recall was initiated because the entire scope of these 4.5mm Cortical Screws is not compatible with the M/DN system. This incompatibility creates a potential for the screw to bind upon entering the nail. Such binding could require the screw to be removed during the surgery or necessitate the removal of the screw after the fracture has healed.
Healthcare providers and patients should verify the compatibility of their orthopedic surgical devices. If you have used or are scheduled to use these specific screws with the M/DN system, contact your healthcare provider or Zimmer, Inc. for guidance on appropriate alternatives or corrective actions.
The recalled product
- Product
- Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
- Manufacturer
- Zimmer, Inc.
- Affected units
- 289,616
Distribution
Distributed nationwide across the United States.
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