Westlake Village, CA, United States
Implant Direct Sybron Manufacturing, LLC recalls
19 recalls recorded since 2018, most recently on 1 May 2025. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls19
Ongoing (FDA)3
Terminated or completed16
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 May 2025
- Reason
- The Drill stop kit contains incorrect components.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, FL, LA, MD, NJ, NV, NY, OH, OK, TN, TX, UT, VA and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2172-2025
- The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release
Ongoing Class II Medical devices
- Recall started
- 2 May 2023
- Reason
- Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.
- Distribution
- US Nationwide distribution in the states of FL, ID, TX, CA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2037-2023
- LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW
Ongoing Class II Medical devices
- Recall started
- 23 September 2021
- Reason
- Packaged dental implant contains a different size then the size declared on the labeling.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0198-2022, Z-0197-2022
- ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
- ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Terminated Class II Medical devices
- Recall started
- 11 October 2019
- Terminated
- 12 April 2024
- Reason
- Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.
- Distribution
- US: AR, AZ, CA, ID, IL, IN, KY, MD, ND, NH, NJ, NV, NY, Oh, OR, PA, TX, UT, WA, WI, WV, GA,MO
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1157-2020
- Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, Size:5.7mmD x 10mmL, 5.7mmD Platform, RxOnly, Sterile R,
Terminated Class II Medical devices
- Recall started
- 7 October 2019
- Terminated
- 28 April 2021
- Reason
- Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.
- Distribution
- U.S. Nationwide distribution in the states of: KS, LA, OH, RI, CA, NJ, MA, FL, UT, ID, MO, WY, WI, PA, WA. O.U.S. (Foreign): DE, IT, HU, JP
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1041-2020
- Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213
Terminated Class II Medical devices
- Recall started
- 9 August 2019
- Terminated
- 27 April 2021
- Reason
- A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.
- Distribution
- U.S.: IN, VA, MD, TX, WA OUS: Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0364-2020
- Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in USA Dental Implants
Terminated Class II Medical devices
- Recall started
- 9 January 2019
- Terminated
- 27 April 2021
- Reason
- Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.
- Distribution
- US: None OUS: Iceland, Sweden, Spain,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1126-2020
- SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708
Completed Class II Medical devices
- Recall started
- 28 November 2018
- Reason
- The peek part was loose on the titanium base of the device which could result in it falling into a patient's mouth during a procedure resulting in aspiration or ingestion.
- Distribution
- Distribution was made to AL, AZ, CA, FL, GA, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, and VA. There was no government/military distribution. Foreign distribution was made to Canada, Armenia, Australia, Denmark, France, Germany, Great Britain, Iceland, Italy
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0791-2020, Z-0790-2020
- ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platform: 3.0mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
- ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platform: 3.4mm, Non-Sterile, Rx. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Terminated Class II Medical devices
- Recall started
- 26 October 2018
- Reason
- packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.
- Distribution
- US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0363-2020
- Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant
Terminated Class II Medical devices
- Recall started
- 6 September 2018
- Terminated
- 1 July 2021
- Reason
- The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.
- Distribution
- US: OH, CO, UT, NY, PA, CA, FL , GA, LA, NE, NJ,SC, MA, VA, UT, OUS: Canada, Australia,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0261-2020
- Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
Terminated Class II Medical devices
- Recall started
- 8 August 2018
- Terminated
- 7 October 2019
- Reason
- Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.
- Distribution
- Worldwide distribution - US Nationwide including the states of CO, HI, ID, KS, NC, OH, OR, PA, SC, TN, and UT, and countries of Canada and the United Arab Emirates.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0018-2020
- ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant D
Terminated Class II Medical devices
- Recall started
- 7 August 2018
- Reason
- The incorrect device was packaged in the vial.
- Distribution
- Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0010-2020
- ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Terminated Class II Medical devices
- Recall started
- 29 May 2018
- Terminated
- 29 July 2020
- Reason
- Cap may be mislabeled with incorrect part number, although the correct part number is on the main vial label.
- Distribution
- Worldwide distribution. US nationwide, Canada, Germany, Great Britain, Kuwait, Lithuania, Monaco, Netherlands, and Slovakia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0089-2019
- Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Platform. Dental implant component, used temporarily during impressions for the prosthetic procedure.
Terminated Class II Medical devices
- Recall started
- 18 May 2018
- Terminated
- 13 July 2020
- Reason
- Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
- Distribution
- CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN & WA; International: Jordan, Great Britain, Germany, Spain, Italy & Poland
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2376-2018
- REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Terminated Class II Medical devices
- Recall started
- 14 March 2018
- Terminated
- 4 June 2018
- Reason
- The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.
- Distribution
- Worldwide Distribution - US Nationwide in the state of AZ, CA, CO, FL, ID, IL, KY, NC, NE, NY, OK, OR, TN, TX, UT, VA, WA, and WI. Foreign distribution was made to Canada, Japan, United Kingdom, France, Switzerland, Netherlands, and Germany.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1917-2018
- ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platform, Part #655010U, Rx, Sterile. Incorrect label on the cap says 4.3mmD Platform 604313U 13mmL. Product Usage: Usage: Dental implants inte
Terminated Class II Medical devices
- Recall started
- 23 January 2018
- Terminated
- 9 August 2018
- Reason
- InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
- Distribution
- CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0539-2018
- Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Terminated Class II Medical devices
- Recall started
- 19 January 2018
- Terminated
- 26 July 2023
- Reason
- The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
- Distribution
- Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1168-2018, Z-1167-2018
- SwishPlus Implant Intended for use in support for fixed bridgework.
- SwishTapered Implant Intended for use in support for fixed bridgework.
Terminated Class II Medical devices
- Recall started
- 3 March 2017
- Terminated
- 6 August 2018
- Reason
- The main vial label lists the incorrect part number, but the cap label is correct.
- Distribution
- Distribution was made to AZ, CA, CO, CT, FL, ID, IL, NC, NJ, NV, NY, PA, TX, UT, VA, and WA. There was no government/military distribution. Foreign distribution was made to Switzerland, Germany, Lithuania, and Spain.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2551-2018
- ImplantDirect, Dental implants intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework
Terminated Class II Medical devices
- Recall started
- 15 November 2016
- Terminated
- 4 June 2018
- Reason
- The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
- Distribution
- Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1920-2018
- ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
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.