Food, drugs, devices › Implant Direct Sybron Manufacturing, LLC
Device recall: Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.5mmD Platform, RxOnly, Sterile R, Made in U
Implant Direct Sybron Manufacturing, LLC (Westlake Village, CA) initiated this device recall on 9 Aug 2019; FDA lists 1 product record under event 83763, classified Class II.
FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 27 Apr 2021. Initiation: voluntary: firm initiated. Implant Direct Sybron Manufacturing, LLC has 30 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA.
Reason for recall
"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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 23 implants | Class II | Terminated | 20 Nov 2019 |
Context
Other enforcement events for Implant Direct Sybron Manufacturing, LLC
All 30 events for Implant Direct Sybron Manufacturing, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "U.S.: IN, VA, MD, TX, WA OUS: Japan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Apr 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.