The Recall Desk
HighFDA (Devices)·Z-1720-2021·Announced 2021-06-09

Zavation spinal orthopedic cement delivery kits recalled for inadequate sterilization

Zavation is recalling 122 units of sterile orthopedic cement delivery kits that may not have been adequately sterilized. The kits were distributed nationwide for use in spinal and orthopedic 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: This is an FDA Class II medical device recall for inadequate sterilization of surgical equipment. No illnesses or hospitalizations have been reported. The product represents a risk-of-harm where injury has not yet been reported, meeting the rubric criterion for High (3) severity.

Plain-English summary

Zavation is recalling 122 units of 10 Gauge Single Cement Delivery kits (code INTVM-SCDK) distributed nationwide for use in orthopedic and spinal procedures.

The products are being recalled because they may not have been adequately sterilized despite being distributed as sterile medical devices. Non-sterilized equipment used in surgical procedures creates a risk of infection.

Affected lot numbers are 20051290, 20081943, 20061420, and 2002439. Healthcare facilities and providers who have received these kits should discontinue use and contact Zavation for replacement or return instructions.

The recalled product

Product
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE: INTVM-SCDK. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic/Spinal Surgical Equipment
Hazard
  • inadequate-sterilization

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 (4)

  • Lot: 20051290
  • 20081943
  • 20061420
  • 2002439

Distribution

Distributed nationwide across the United States.

Related recalls

Same category