Integra External Fixation System Rocker Bottom Recall for Loose Silicone Insert
Integra LifeSciences Corp. is recalling 27 units of the External Fixation System Rocker Bottom because the embedded silicone insert may become dislodged or loose.
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: The recall is classified as FDA Class II, and the hazard involves a component that may become dislodged, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling 27 units of the Integra External Fixation System Rocker Bottom, Model # 12225400, Lot # PN625. The product is used in the treatment of bone conditions amenable to treatment by the use of external fixation.
The recall is being conducted because the silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
The affected units were distributed in the United States to the states of Florida, Virginia, Oklahoma, Colorado, the District of Columbia, and Indiana.
The recalled product
- Product
- Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Orthopedic
- Hazard
- Affected units
- 27
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)
- Lot # PN625.
Distribution
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