Keystone Dental Inc
Complete recall history across all FDA and CPSC categories — 16 total recalls
Keystone Dental Inc appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (16)
FDA medical device enforcement actions by Keystone Dental Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Long Part Number: 60-70101 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly o... | Class II |
| Feb 22, 2019 | Paltop 1.25 Hex Drivers, Short Part Number: 60-70102 | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly o... | Class II |
| Feb 22, 2019 | Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgi... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly o... | Class II |
| Feb 22, 2019 | Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical an... | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly o... | Class II |
| May 1, 2018 | Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental im... | The implants are mislabeled. | Class II |
| Mar 13, 2018 | Genesis Surgical Cassette Tapered Implants are intended for placement fo... | The surgical cassette contained extra-large white grommets making the 3.8 mm ... | Class II |
| Jan 24, 2018 | Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended... | The cutting edge of tissue punches may be potentially damaged with small dent... | Class II |
| Oct 16, 2017 | STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Numbe... | A locking plastic abutment sleeve, used by dental technicians in dental labor... | Class III |
| Aug 25, 2017 | Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants ... | The recalled units are mislabeled with an incorrect expiration date. The expi... | Class II |
| Jun 20, 2017 | Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog... | Abutments are unable to accept the final abutment screw | Class II |
| Jun 16, 2017 | Max Implant System - Bone Tap for use with 7.0mm diameter Max Implant, Catalo... | An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with... | Class II |
| Mar 9, 2017 | Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection ... | Straight PrimaConnex Implants contained Tapered PrimaConnex Implants | Class II |
| Sep 15, 2016 | Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 ... | Small diameter (SD) cover screw was packaged with the regular diameter implan... | Class II |
| Mar 11, 2013 | PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog N... | Mislabeled: Cover screw that was in the package was a WD cover screw and not ... | Class II |
| Jul 5, 2011 | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Ge... | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Gene... | Class II |
| Jul 5, 2011 | Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 ... | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Gene... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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