Implant Direct IO Scan Adapter Recall Due to Loose Component
Implant Direct Sybron Manufacturing is recalling 232 IO Scan Adapters because a loose part could fall into a patient's mouth, causing aspiration or ingestion.
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 involves a risk-of-harm product (medical device) where injury (aspiration or ingestion) has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Implant Direct Sybron Manufacturing, LLC is recalling 232 units of the ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The affected devices are identified by lot numbers 104151, 106478, 114914, and 124072.
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 of the affected devices 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 providers and patients should contact the manufacturer for further instructions on how to handle the affected devices.
The recalled product
- Product
- ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
- Manufacturer
- Implant Direct Sybron Manufacturing, LLC
- Hazard
- Affected units
- 232
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 (4)
- Lot numbers 104151
- 106478
- 114914
- and 124072.
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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