The Recall Desk
HighFDA (Devices)·Z-1741-2021·Announced 2021-06-09

Zavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization

Zavation is recalling 10G Double Cement Delivery Kits used in orthopedic and spinal procedures due to potential inadequate sterilization, creating a risk of surgical site 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: The source reports no illnesses, injuries, or deaths. The product is an FDA Class II medical device with an identified sterilization defect creating a theoretical infection risk in surgical applications. This meets the criterion for score 3: 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Zavation is recalling 10G Double Cement Delivery Kits (8 fillers), medical devices used in orthopedic and spinal surgical procedures. The kits were distributed as sterile products.

According to the FDA, the distributed products may not have been adequately sterilized. Inadequate sterilization of surgical devices presents a potential risk of infection at surgical sites.

The products have been distributed nationwide across the United States. Lot numbers and distribution timeframes are pending.

The recalled product

Product
10G DOUBLE CEMENT DELIVERY KIT (8 FILLERS). For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Spinal Surgery Equipment
Hazard
  • sterilization-defect
  • 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)

  • Pending

Distribution

Distributed nationwide across the United States.

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