The Recall Desk
HighFDA (Devices)·Z-1717-2021·Announced 2021-06-09

Orthopedic spinal implants recalled due to inadequate sterilization

Zavation is recalling 7 units of 11G DIRECT SINGLE spinal implants (lots 2001185 and 2001243) because products distributed as sterile may not have been adequately sterilized. The devices were distributed nationwide.

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 a Class II medical device recall with no reported hospitalizations or injuries. The inadequate sterilization of orthopedic implants poses a risk of infection to patients receiving these devices. Per the severity rubric, this qualifies as Score 3 (High): 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Zavation is recalling 7 units of the 11G DIRECT SINGLE implant delivery system (lot numbers 2001185 and 2001243) for use in orthopedic and spinal procedures. Each kit includes 4 fillers and 4 syringes.

The products were distributed as sterile but may not have been adequately sterilized. Non-sterile orthopedic implants used in spinal procedures pose a risk of infection to patients receiving these devices.

The affected devices were distributed nationwide. Patients who received these implants and healthcare providers with these products in inventory should contact Zavation for guidance on next steps.

The recalled product

Product
11G DIRECT SINGLE - DELIVERY (4 FILLERS-4 SYRINGES) CODE: INTVMN-SCDK. For use in Orthopedic / spinal procedures.
Manufacturer
Zavation
Category
Medical Device — Orthopedic Implant
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 (2)

  • Lot: 2001185
  • 2001243

Distribution

Distributed nationwide across the United States.

Related recalls

Same category