The Recall Desk
ModerateFDA (Devices)·Z-1835-2017·Announced 2017-04-26

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.

What this means for you

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.
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

Distributed nationwide across the United States.

The notice also names 7 states specifically: