Zavation 10 Gauge Direct Access Diamond Tip Devices Recalled for Sterilization
Zavation is recalling 89 units of 10 Gauge Direct Access Diamond Tip devices (Lot 11285ZV, 2001200) distributed nationwide for orthopedic spinal procedures because they may not have been adequately sterilized.
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 involving a risk-of-harm product (surgical instrumentation for spinal procedures) where inadequate sterilization poses infection risk. No illnesses or injuries have been reported, placing this in the High category per the rubric.
Plain-English summary
Zavation is recalling 89 units of 10 Gauge Direct Access Diamond Tip surgical devices (Model Code INTVM-DWCd). These instruments are used in orthopedic and spinal surgical procedures and were distributed to facilities nationwide in the United States.
The devices were distributed as sterile-packaged products, but they may not have been adequately sterilized during manufacturing. Inadequate sterilization of surgical instruments poses a potential risk of infection when the devices are used in orthopedic and spinal procedures.
The recalled devices are identified by Lot Numbers 11285ZV and 2001200. Patients and healthcare providers who have received or used these devices should be aware of this recall.
The recalled product
- Product
- 10 GAUGE DIRECT ACCESS DIAMOND TIP, CODE: INTVM-DWCd. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 89
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: 11285ZV
- 2001200
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 71 recalled by Zavation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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