Food, drugs, devices › Implant Direct Sybron Manufacturing, LLC
Device recall: Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
FDA enforcement event 78917 is a device recall by Implant Direct Sybron Manufacturing, LLC of Westlake Village, CA, initiated 23 Jan 2018 and classified Class II, with 1 product record.
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 9 Aug 2018. 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
"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"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0539-2018 | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform | 55 units | Class II | Terminated | 14 Feb 2018 |
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: "InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized."
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: "CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Aug 2018. "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.