Ace Surgical Supply Recalls Incorrectly Packaged Dental Abutments
Ace Surgical Supply Co., Inc. is recalling 87 INFINITY Internal Hex Healing Abutments because the incorrect device was packaged.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a packaging error (incorrect device), which is a moderate risk compared to active contamination or structural failure.
Plain-English summary
Ace Surgical Supply Co., Inc. is recalling 87 units of the INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight (Product Code: 20145473). The recall is due to a packaging error where the incorrect device was packaged.
The affected product is a non-implantable dental abutment. The specific lot number is 16100050. The products were distributed nationwide in the states of California, Connecticut, Florida, New York, Ohio, Pennsylvania, and Utah.
Consumers and healthcare providers should stop using the affected products and contact Ace Surgical Supply Co., Inc. for further instructions or a return.
The recalled product
- Product
- INFINITY Internal Hex Healing Abutment, 4.5mm Platform, 4.7mm CW-3mm CH Straight; Product Code: 20145473 Product Usage: Non implantable dental abutment.
- Manufacturer
- Ace Surgical Supply Co., Inc.
- Category
- Medical Device — Dental Abutment
- Hazard
- Affected units
- 87
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 Number: 16100050
Distribution
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