Surgical knee navigation implant recalled over sterilization failures
Orthosoft's NavitrackER knee navigation system may lack proper sterilization. The product was distributed without passing required sterilization tests, risking 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: This FDA Class II recall involves no reported illnesses or injuries, but the hazard—insufficient sterilization of a surgical implant—is serious and real. The risk is theoretical but substantial, justifying a High severity score.
Plain-English summary
NavitrackER Kit A: Knee (Model Number 20-8000-000-07), manufactured by Orthosoft, Inc. dba Zimmer CAS, has been recalled. The product was released for distribution without passing required sterilization tests.
The recall affects 14 units distributed in the United States (Arkansas, New York, Ohio, Tennessee, and Texas) and 132 units distributed internationally (Canada and the Netherlands). The affected lot number is 110221A1.
The primary concern is insufficient sterility of the product. Sterilization failures in surgical implants can lead to infection, potentially requiring additional surgical intervention.
The recalled product
- Product
- NavitrackER Kit A: Knee, Model Number 20-8000-000-07,
- Manufacturer
- Orthosoft, Inc. dba Zimmer CAS
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number 110221A1 UDI Number (01)00889024304222 (17)231103(10)110221A1
Distribution
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