Keystone Dental Recalls Max Implant System Bone Taps Due to Mislabeling
Keystone Dental Inc. is recalling 72 units of the Max Implant System Bone Tap because an 8mm diameter tap was incorrectly marked and labeled as 7mm.
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 corresponds to a moderate severity score. The hazard is a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Keystone Dental Inc. is recalling 72 units of the Max Implant System Bone Tap, Catalog Number D-TAP-MAX7-7, Lot 31444. The recall is due to a labeling error where an 8mm diameter bone tap was laser marked as 7mm diameter and packed with a 7mm label.
The affected products were distributed nationwide in the United States to the states of CA, CO, FL, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NH, NY, OH, PA, TN, TX, UT, VA, VT, WA, WI, and WV, as well as internationally to Canada. These dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or lower jaw.
Consumers and healthcare providers should stop using the affected bone taps and contact Keystone Dental Inc. for further instructions.
The recalled product
- Product
- Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalog Number D-TAP-MAX7-7 Dental implants are intended for use as anchors of fixed or semi-fixed dental crowns, bridges, and overdentures in patients with partial or full edentulism of the upper or…
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 72
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 (2)
- Catalog Number D-TAP-MAX7-7
- Lot 31444
Distribution
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