The Recall Desk
HighFDA (Devices)·Z-0721-2022·Announced 2022-03-09

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.

What this means for you

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
Category
Medical Device — Surgical implant / Navigation system
Hazard
  • sterilization-failure
  • infection-risk

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

Distributed nationwide across the United States.

Related recalls

Same category