Cuyahoga Falls, OH, United States
Coltene Whaledent Inc recalls
6 recalls recorded since 2018, most recently on 20 January 2023. 4 are listed as ongoing. Status and classification are as published by the FDA.
Recalls6
Ongoing (FDA)4
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 20 January 2023
- Reason
- Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
- Distribution
- Nationwide Foreign: Canada Germany Indonesia Ireland Lebanon Saudia Arabia Turkey
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1208-2023
- SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. Model Number
Ongoing Class II Medical devices
- Recall started
- 18 March 2021
- Reason
- The incorrect dental pins were packaged and subsequently distributed.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of NJ, IN, NC, IL. GA, CA, NY, PA and the countries of Canada, Venezuela.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1494-2021
- Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted into the teeth or for lab use for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with
Ongoing Class II Medical devices
- Recall started
- 20 October 2020
- Reason
- The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
- Distribution
- Sold to distributors located in FL, NV, PA, TN, TX. Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0467-2021, Z-0465-2021, Z-0464-2021, Z-0466-2021, Z-0468-2021
- CEI Cutting Edge Instruments (PTC-57C)
- FG 57 100057X (100057X)
- Alpen Clinic 100 Carbide Instruments (R100057C)
- Clinic Pack 100 Pieces FG 57 100057C (100057C)
- Strauss 25 Carbide Dental Burs (100057XXV)
Ongoing Class II Medical devices
- Recall started
- 3 June 2020
- Reason
- Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
- Distribution
- Pending
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2422-2020, Z-2421-2020, Z-2419-2020, Z-2420-2020
- HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove
- HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove th
- HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove t
- HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the
Terminated Class II Medical devices
- Recall started
- 21 August 2018
- Terminated
- 10 April 2020
- Reason
- ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
- Distribution
- US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0376-2019
- ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled
Terminated Class II Medical devices
- Recall started
- 13 April 2018
- Terminated
- 8 April 2019
- Reason
- The products are labeled with an incorrect product number.
- Distribution
- The products were distributed to the following US states: NY. The products were distributed to the following foreign countries: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1883-2018
- Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone.
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.