The Recall Desk
HighFDA (Devices)·Z-1742-2021·Announced 2021-06-09

Orthopedic bone access kits recalled for inadequate sterilization

Zavation recalled its 10G Direct Double Bone Access Kit because some units distributed as sterile may not have been adequately sterilized. Affected devices are used in orthopedic and spinal procedures.

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 FDA classified this as a Class II medical device recall. Inadequate sterilization of surgical instruments poses a potential infection risk to patients, but no illnesses have been reported. This fits the rubric criterion for high-risk products where injury has not yet been reported.

Plain-English summary

Zavation has recalled the 10G Direct Double Bone Access Kit, a medical device used in orthopedic and spinal procedures. According to the recall notice, some units that were distributed as sterile may not have been adequately sterilized.

Surgical devices that have not been properly sterilized could potentially expose patients to infection. These devices have been distributed nationwide throughout the United States.

Patients who have had procedures using this device should contact their healthcare provider with any concerns related to their procedure or recovery.

The recalled product

Product
10G DIRECT DOUBLE BONE ACCESS KIT. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Surgical
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)

  • Pending

Distribution

Distributed nationwide across the United States.

Related recalls

Same category