Food, drugs, devices › Implant Direct Sybron Manufacturing, LLC
Device recall: ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislab
Implant Direct Sybron Manufacturing, LLC (Westlake Village, CA) initiated this device recall on 8 Aug 2018; FDA lists 1 product record under event 83518, 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, terminated 7 Oct 2019. 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
"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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing… | 22 vials | Class II | Terminated | 9 Oct 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: "Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number."
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: "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."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Oct 2019. "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.