Zimmer GmbH Recalls Normed Charcot Osteotome Chisels for Disinfection Gap
Zimmer GmbH is recalling Normed Charcot Osteotome Chisels because a gap between the handle and metal chisel may prevent proper disinfection or sterilization between uses.
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 improper sterilization of a medical device, which poses a risk of harm (infection) even though specific injuries or illnesses are not reported in the source text.
Plain-English summary
Zimmer GmbH is recalling Normed Charcot Osteotome Chisels in various sizes. The recall is due to a potential gap between the handle and the metal chisel, which can lead to a failure to properly disinfect or sterilize the instrument between uses.
The affected products include specific models such as 26.08.506, 26.08.507, 26.08.508, 26.08.509, 26.08.619, 26.08.718, and 26.08.910. The source text notes that distribution occurred in Colorado, Indiana, Texas, and Illinois. Several other model numbers are listed in the product information but are marked as having no US distribution.
Healthcare facilities and users should stop using the affected chisels and contact Zimmer GmbH for further instructions on the recall. The hazard is identified as a risk of improper sterilization, which could potentially lead to infection if the instruments are used without adequate cleaning.
The recalled product
- Product
- Normed Charcot Osteotome Chisel (Various sizes)
- Manufacturer
- Zimmer GmbH
Distribution
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