REPLANT 5 — Class II medical device recall Z-2376-2018
Terminated recall by Implant Direct Sybron Manufacturing, LLC, reported 2018-07-11, distributed in CA, FL, GA, IL, LA, MI, MT, NC…. Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
| Recall number | Z-2376-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Implant Direct Sybron Manufacturing, LLC, Thousand Oaks, CA, United States |
| Recall initiated | 2018-05-18 |
| Classified | 2018-07-05 |
| Reported by FDA | 2018-07-11 |
| Terminated | 2020-07-13 |
| Distributed | CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN, WA |
| Countries outside the US | DE, ES, GB, IT, JO, PL |
| Quantity | 60 units |
| Reason classes | specification failure |
| Lot numbers | 45353, 66011, 75850 |
| Model numbers | 6050-52-60 |
Product
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Reason for recall
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
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-2376-2018. 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.