Zavation 10G Cement Delivery Cannula Recalled for Inadequate Sterilization
Zavation is recalling its 10G Cement Delivery Cannula used in orthopedic and spinal procedures nationwide due to products distributed as sterile not being adequately sterilized.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with no illnesses or injuries reported. The hazard—inadequate sterilization of a surgical device—represents a risk of harm in a high-risk application (spinal procedures), meeting the criterion for High severity when injury has not yet been reported.
Plain-English summary
Zavation is recalling the 10G Cement Delivery Cannula, a medical device used in orthopedic and spinal procedures. The device was distributed nationwide throughout the United States.
The product was distributed as sterile, but may not have been adequately sterilized. This poses a potential risk of infection or contamination when the device is used in surgical procedures.
Patients and healthcare providers who have this device should stop using it immediately and contact their healthcare provider for guidance on next steps. Zavation should be contacted regarding return and replacement of affected units.
The recalled product
- Product
- 10G CEMENT DELIVERY CANNULA. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
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 (1)
- Pending
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.
See all 71 products in this recall →Related recalls
Same manufacturer · Zavation
See all →- HighZavation 10G Direct Double Bone Access Kit May Not Be Properly Sterilized
FDA (Devices) · 2021-06-09
- HighZVplasty System spinal implant recalled due to inadequate sterilization
FDA (Devices) · 2021-06-09
- HighZVplasty orthopedic surgical devices may lack adequate sterilization
FDA (Devices) · 2021-06-09
- HighZavation Orthopedic Cement Delivery Kit Recalled for Inadequate Sterilization
FDA (Devices) · 2021-06-09
- HighOrthopedic bone access kits recalled for inadequate sterilization
FDA (Devices) · 2021-06-09
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- SevereBiopsybell 10 Gauge Cement Delivery Cannula Recalled for Sterility Concerns
FDA (Devices) · 2021-05-26
- SevereStryker Recalls 11g Verteport Cement Cannula Due to Sterility Concerns
FDA (Devices) · 2018-04-04
- HighBiopsybell Cement Delivery Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2021-05-26
- HighBiopsybell 10G Direct Working Cannula Recalled for Sterilization Concerns
FDA (Devices) · 2021-05-26
- HighParagon 28 Phantom TTC Nail recalled for unsterilized distribution
FDA (Devices) · 2024-03-13
- HighSynthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed
FDA (Devices) · 2024-03-13