Recall record at a glance
| Official record | Z-0455-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Straumann Manufacturing, Inc. |
| Report date | Nov 21, 2018 |
| Recall initiation date | Oct 2, 2018 |
| Quantity | 21 units |
| Location | Andover, MA, United States |
Official product description
Neodent GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are intermediary prosthetic components to be installed onto GM implants to support the final prosthesis. They are provided in a rotational shape for the coupling with the prosthesis and in different gingival heights to match the variations in mucosal thickness. The GM Exact Mini Conical abutment is provided angled. They are indicated for screw-retained multiple-unit prostheses onto implants Article Number: 115244
Why the product was recalled
Laser engraved label does not match with the item in the package
Distribution information
US nationwide distribution in the states of GA, TX , VA.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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