Zavation OsteoFlex Cement Surgical System Recalled Due to Sterilization Concerns
Zavation is recalling OsteoFlex Cement and Mixing System used in spinal and orthopedic surgery due to potential sterilization failures. The 846 units distributed nationwide may not be adequately sterilized, creating a contamination risk.
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: FDA Class II medical device recall for sterilization failure on surgical cement used in spinal and orthopedic procedures. No illnesses or injuries have been reported, but this qualifies as a risk-of-harm product where serious infection is a potential consequence of inadequate sterilization.
Plain-English summary
Zavation Medical has recalled 846 units of OsteoFlex Cement and Mixing System due to sterilization concerns. The products, which are used in orthopedic and spinal surgical procedures, were distributed nationwide but may not have been adequately sterilized.
Inadequately sterilized surgical materials pose a risk of surgical site contamination and infection. Healthcare facilities using this product should identify any units with the affected lot numbers and cease use immediately.
The recall affects units with the following lot numbers: 13844ZV, 12320ZV, 14359ZV, 14171ZV, 13887ZV, 12670ZV, 11759ZV, 11850ZV, 13750ZV, 14273ZV, 14017ZV, 13665ZV, 12766ZV, 12037ZV, 14100ZV, 11693ZV, 14472ZV, 14388ZV, 13651ZV, and 13876ZV. Healthcare providers should verify lot numbers against records and consult with their surgical teams. Patients who received procedures using this product should contact their healthcare provider if they experience signs of infection or other complications.
The recalled product
- Product
- OsteoFlex Cement and Mixing System, REF VCF-OSFL. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 846
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 (20)
- Lot Numbers: 13844ZV
- 12320ZV
- 14359ZV
- 14171ZV
- 13887ZV
- 12670ZV
- 11759ZV
- 11850ZV
- 13750ZV
- 14273ZV
- 14017ZV
- 13665ZV
- 12766ZV
- 12037ZV
- 14100ZV
- 11693ZV
- 14472ZV
- 14388ZV
- 13651ZV
- 13876ZV
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
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