Burlington, MA, United States
Keystone Dental Inc recalls
8 recalls recorded since 2018, most recently on 22 February 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)0
Terminated or completed8
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 22 February 2019
- Terminated
- 19 June 2020
- Reason
- Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
- Distribution
- FL, MA, SC, VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1061-2019, Z-1062-2019, Z-1064-2019, Z-1063-2019
- Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
- Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
- Paltop 1.25 Hex Drivers, Short Part Number: 60-70102
- Paltop 1.25 Hex Drivers, Long Part Number: 60-70101
Terminated Class II Medical devices
- Recall started
- 1 May 2018
- Terminated
- 14 September 2018
- Reason
- The implants are mislabeled.
- Distribution
- US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2162-2018
- Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includi
Terminated Class II Medical devices
- Recall started
- 13 March 2018
- Terminated
- 23 July 2018
- Reason
- The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
- Distribution
- USA (nationwide) Distribution and Internationally to Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1485-2018
- Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
Terminated Class II Medical devices
- Recall started
- 24 January 2018
- Terminated
- 30 July 2018
- Reason
- The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
- Distribution
- Worldwide Distribution -- US, to the state of California; and, the countries of Canada and Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1443-2018
- Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
Terminated Class III Medical devices
- Recall started
- 16 October 2017
- Terminated
- 17 April 2019
- Reason
- A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
- Distribution
- International Distribution to: Germany only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1179-2018
- STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Terminated Class II Medical devices
- Recall started
- 25 August 2017
- Terminated
- 16 April 2019
- Reason
- The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
- Distribution
- Nationally.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0727-2018
- Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restora
Terminated Class II Medical devices
- Recall started
- 20 June 2017
- Terminated
- 9 April 2018
- Reason
- Abutments are unable to accept the final abutment screw
- Distribution
- US Nationwide Distribution in the states of ND, NJ & MA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0608-2018
- Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restoratio
Terminated Class II Medical devices
- Recall started
- 16 June 2017
- Terminated
- 16 April 2019
- Reason
- An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
- Distribution
- USA (nationwide) Distribution 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; and Internationally to Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0718-2018
- 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 p
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.