OsteoFlex Bone Cement Recalled Due to Inadequate Sterilization
Zavation's OsteoFlex bone cement distributed nationwide may not have been adequately sterilized. Patients who received this sterile surgical product in orthopedic or spinal procedures should contact their healthcare provider.
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: Class II recall of sterile surgical material with sterilization process failure. No illnesses or injuries are reported. The risk of infection from non-sterile implant material in surgical sites is significant but currently unconfirmed.
Plain-English summary
Zavation is recalling OsteoFlex bone cement (reference numbers INTV-OSFL and INTV-OSFL-LV) distributed across the United States. The product is used in orthopedic and spinal procedures.
The recall was initiated because products distributed as sterile may not have been adequately sterilized. This affects approximately 200 units across multiple lot numbers: 11395ZV, 11285ZV, 11574ZV, and 11471ZV for INTV-OSFL, and lot number 12386ZV for INTV-OSFL-LV.
Patients who received this bone cement during orthopedic or spinal procedures may be at risk if the material was not properly sterilized. Inadequate sterilization of surgical materials used in invasive procedures can increase the risk of infection. Patients who may have received a recalled lot should contact their healthcare provider immediately for evaluation and guidance.
The recalled product
- Product
- OsteoFlex BONE CEMENT, REF Numbers: a) INTV-OSFL b) INTV-OSFL-LV. For use in Orthopedic / spinal procedures.
- Manufacturer
- Zavation
- Affected units
- 200
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 (6)
- a) INTV-OSFL
- Lot Numbers: 11395ZV
- 11285ZV
- 11574ZV
- 11471ZV b) INTV-OSFL-LV
- Lot Numbers: 12386ZV
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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