Recall record at a glance
| Official record | Z-0790-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC |
| Report date | Jan 15, 2020 |
| Recall initiation date | Nov 28, 2018 |
| Quantity | 274 devices |
| Location | Thousand Oaks, CA, United States |
Official product description
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.
Why the product was recalled
The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
Distribution information
Distribution was made to AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy, Lithuania, Netherlands, Poland, Spain, Sweden, and Switzerland.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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