FDA Device recall Z-0539-2018
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform by Implant Direct Sybron Manufacturing, citing interActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0539-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-23 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | CA, CO, FL, IA, ID, NJ, SC, VA |
Product
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Reason
InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Identifiers
| code_info | Lot Number 104203 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0539-2018%22
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