Zavation Spinal Stylet Instruments Recalled for Inadequate Sterilization
Zavation is recalling 56 units of 10 Gauge Direct Unilateral Stylets used in spinal procedures because products distributed as sterile may not have been adequately sterilized. Patients who received this device should contact their healthcare provider.
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 recall of a surgical instrument used in invasive spinal procedures. Although no illnesses or injuries have been reported, inadequate sterilization of surgical devices poses a significant risk of infection to patients who received the implant, meeting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zavation is recalling 56 units of its 10 Gauge Direct Unilateral Stylet with diamond and bevel configurations (model INTVM-DSSKBD), medical devices used in orthopedic and spinal surgical procedures.
The recall was issued because products distributed as sterile may not have been adequately sterilized. Non-sterile surgical instruments pose a risk of infection when used in invasive procedures.
Affected product batches are 19102741, 200127, and 2001246. The devices were distributed nationwide in the United States.
Patients who underwent spinal procedures using this device should contact their healthcare provider immediately with their batch number for guidance on appropriate follow-up care.
The recalled product
- Product
- 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), INTVM-DSSKBD. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- 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 (3)
- Product Batch: 19102741
- 200127
- 2001246
Distribution
Distributed nationwide across the United States.
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