CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report
ZVplasty Unipedicular Cement Delivery Cannula Kit recalled by Zavation
Zavation is recalling ZVplasty Unipedicular Cement Delivery Cannula Kit, distributed nationwide in the US. The recall was initiated on 25 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1721-2021
- FDA event ID
- 87661
- Recalling firm
- Zavation, Flowood, MS
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2021
- FDA classified
- 1 Jun 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 25 Mar 2021 | Recall initiated by company | |
| 1 Jun 2021 | Classified by FDA | +68 days |
| 9 Jun 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Products distributed as sterile may not have been adequately sterilized
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ZVplasty Unipedicular Cement Delivery Cannula Kit, 10 Gauge, REF VCF-SCDK. For use in Orthopedic / spinal procedures.
Where it was distributed
US nationwide distribution.
Questions about this recall
Why was it recalled?
Products distributed as sterile may not have been adequately sterilized
Which lots are affected?
Lot: 2003661, 19113051, 20071709, 20071843
Where was it sold?
US nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
70 other products · FDA event 87661This product is part of a recall event; the main page for the event is Direct Double Bone Access Kit recalled by Zavation.
More recalls from Zavation
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ZVplasty Biopsy Device recalled by Zavation | Zavation | Sterility | Nationwide |
| Device | CLASS II | ZVplasty, Direct Bipedicular, Bone Access Kit with Coxaial Cannula recalled | Zavation | Sterility | Nationwide |
| Device | CLASS II | ZVplasty Cement Delivery Cannula recalled by Zavation | Zavation | Sterility | Nationwide |
| Device | CLASS II | Cemix - Cement Mixing System Sterile recalled by Zavation | Zavation | Sterility | Nationwide |
| Device | CLASS II | Beveled Trocar/cannula recalled by Zavation | Zavation | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |