The Recall Desk
HighFDA (Devices)·Z-1744-2021·Announced 2021-06-09

Zavation Orthopedic Cement Delivery System Recalled for Sterilization Failure

Zavation recalled its 10-gauge orthopedic cement delivery system because products distributed as sterile may not have been adequately sterilized. Healthcare providers and patients with concerns should contact Zavation.

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 surgical devices where inadequate sterilization presents a significant risk of infection and surgical complications in patients undergoing orthopedic or spinal procedures. No illnesses or injuries have been reported, placing this in the high-risk category for products where injury has not yet occurred.

Plain-English summary

Zavation has recalled its 10-gauge single cement delivery system with four fillers and four syringes. These products are labeled as sterile and intended for use in orthopedic and spinal surgical procedures.

The recall was initiated because products distributed as sterile may not have been adequately sterilized. This creates a potential risk of infection or other complications when used in surgical procedures.

The affected devices were distributed nationwide in the United States. Patients and healthcare providers with questions about this product should contact Zavation or their healthcare provider.

The recalled product

Product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES STERILE. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic Surgical Device
Hazard
  • inadequate-sterilization
  • 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.

Related recalls

Same category