Food, drugs, devices › Implant Direct Sybron Manufacturing, LLC
Device recall: Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only,
Implant Direct Sybron Manufacturing, LLC (Westlake Village, CA) initiated this device recall on 26 Oct 2018; FDA lists 1 product record under event 83794, 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. 92% of the 1,074 device enforcement events initiated in 2018 carry the same class.
Status: Terminated. 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
"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,"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 | 53 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: "packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit."
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: "US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,"
Is the recall still ongoing?
FDA lists the status as Terminated. "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.