Implant Direct IO Scan Adapter Recalled Due to Loose Component
Implant Direct is recalling 274 IO Scan Adapters because a loose part could fall into a patient's mouth, posing a risk of aspiration or ingestion.
What this means for you
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 involves a risk-of-harm product where a component could be aspirated or ingested, but the source text does not report any actual injuries or illnesses.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 274 units of the ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile. The recall affects devices with lot numbers 104479 and 104963.
The recall was initiated because the peek part was loose on the titanium base of the device. This defect could result in the part falling into a patient's mouth during a procedure, which could lead to aspiration or ingestion.
Distribution was made to 26 U.S. states and 13 foreign countries, including Canada, Australia, and several European nations. There was no government or military distribution. Healthcare professionals should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 274
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 numbers 104479 and 104963.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Implant Direct Sybron Manufacturing, LLC 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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