The Recall Desk
HighFDA (Devices)·Z-1749-2021·Announced 2021-06-09

Zavation Orthopedic Spinal Stylets Recalled for Inadequate Sterilization

Zavation has recalled 10 gauge direct unilateral sterile stylets used in orthopedic and spinal procedures due to inadequate sterilization. Products distributed as sterile may not meet sterilization standards.

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: FDA Class II medical device with potential for infection due to sterilization defect. No illnesses or injuries have been reported; the hazard is theoretical, making this a high-risk product without reported harm.

Plain-English summary

Zavation is recalling 10 gauge direct unilateral sterile stylets (with diamond and bevel configurations) used in orthopedic and spinal procedures. The recalled devices were distributed nationwide in the United States.

Products distributed as sterile may not have been adequately sterilized. Inadequate sterilization of surgical instruments poses a potential risk of infection during spinal and orthopedic procedures.

Patients who have undergone procedures using these stylets should consult their healthcare provider with any concerns. Healthcare providers should stop using the recalled devices and contact Zavation for instructions regarding proper handling and replacement options.

The recalled product

Product
10 GAUGE DIRECT UNILATERAL STYLET (1 X DIAMOND 1 X BEVEL) STERILE. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic / Surgical Instruments
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