FDA Device recall Z-2376-2018
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
- FDA Device
- Class II
- terminated
- Published 2018-07-11
On 2018-07-11 the FDA classified a Class II recall of REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 by Implant Direct Sybron Manufacturing, citing due to out of specification, the clinician would not be able to fit and engage the abutment with the implant.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2376-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-18 |
| Published | 2018-07-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Implant Direct Sybron Manufacturing |
| Distribution | CA, FL, GA, IL, LA, MI, MT, NC, NJ, NY, OK, OR, SC, SD, TN, WA |
Product
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Reason
Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Identifiers
| code_info | Lot numbers: 45353, 66011, and 75850 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Implant Direct Sybron Manufacturing recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2376-2018%22
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