Zavation CEMIX Orthopedic Cement Mixing System Sterilization Recall
Zavation recalled 197 CEMIX cement mixing system units due to inadequate sterilization for orthopedic and spinal surgical use.
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: FDA Class II medical device recall. No illnesses or injuries are reported. However, sterilization failure in surgical instruments poses a significant infection risk. Per rubric criteria, risk-of-harm products without reported injury receive a High (3) score.
Plain-English summary
Zavation issued a recall of CEMIX sterile cement mixing system units (lot codes 2003787 and 2001228) due to inadequate sterilization. The system is designed for use in orthopedic and spinal surgical procedures. The recall affects 197 units that were distributed nationwide.
Products marketed as sterile may not have been adequately sterilized. The FDA classified this as a Class II recall.
The recalled product
- Product
- CEMIX - CEMENT MIXING SYSTEM STERILE, CODE INTV-MMS. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Hazard
- Affected units
- 197
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 (2)
- Lot: 2003787
- 2001228
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 71 recalled by Zavation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 71 products in this recall →Related recalls
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