Implant Direct — Class II medical device recall Z-0539-2018
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2018-02-14, distributed in CA, CO, FL, IA, ID, NJ, SC, VA. InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
| Recall number | Z-0539-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Westlake Village, CA, United States |
| Recall initiated | 2018-01-23 |
| Classified | 2018-02-06 |
| Reported by FDA | 2018-02-14 |
| Terminated | 2018-08-09 |
| Distributed | CA, CO, FL, IA, ID, NJ, SC, VA |
| Countries outside the US | NL |
| Quantity | 55 units |
| Reason classes | labeling, sterility |
| Lot numbers | 104203 |
| Model numbers | 3.0MMD, 5.0MML, 6530-15 |
Product
Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform
Reason for recall
InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0539-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.