Zimmer Natural Nail CM Long Intramedullary Fixation Rods Recalled for Packaging Defects
Zimmer GmbH is recalling 57,603 units of Natural Nail CM Long intramedullary fixation rods because compromised outer trays may lead to periprosthetic infection.
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 is classified as FDA Class II. The hazard involves a risk of periprosthetic infection, which is a significant health risk, but the source text does not report any specific cases of injury, hospitalization, or death.
Plain-English summary
Zimmer GmbH is recalling 57,603 units of the Zimmer Natural Nail CM Long Intramedullary Fixation Rod. The product is intended for temporary fracture fixation and stabilization of the bone. The recall covers all lots of the affected item numbers, which were distributed nationwide in the United States.
The recall was initiated because testing revealed that in about 5% of samples, the outer tray was compromised. A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If compromised packaging is not detected prior to or during surgery, it may lead to periprosthetic infection, which may result in revision or multi-stage revision to treat the infection.
Healthcare providers and patients should contact Zimmer GmbH for further information regarding the recall and replacement of affected devices.
The recalled product
- Product
- Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
- Manufacturer
- Zimmer Gmbh
- Affected units
- 57,603
Distribution
Distributed nationwide across the United States.
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