Zavation Orthopedic Stylet 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. Affected units 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 recall of a sterile medical device used in invasive spinal procedures where the hazard (inadequate sterilization) is theoretical with no reported illnesses or injuries. Per the rubric, risk-of-harm products without reported injuries score 3 (High).
Plain-English summary
Zavation is recalling 10 gauge direct unilateral stylets (code INTVM-DSSKbd) used in orthopedic and spinal surgical procedures. The affected product is available with two tip variations: diamond and bevel. A total of 56 units were distributed nationwide in affected lot numbers 2001246, 19102741, and 200127.
The FDA identified that these devices, distributed as sterile, may not have been adequately sterilized. Inadequate sterilization of instruments used in invasive spinal procedures poses a risk of serious infection or device-related complications.
Medical facilities and surgical centers that received these stylets should stop using them immediately and contact Zavation or their supplier for replacement products and instructions on device disposal. Healthcare providers should verify their inventory against the affected lot numbers.
The recalled product
- Product
- 10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE 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)
- Lot: 2001246
- 19102741
- 200127
Distribution
Distributed nationwide across the United States.
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