Implant Direct Sybron Manufacturing LLC Recall 88859
Description: ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Implant Direct Sybron Manufacturing LLC Recall 88859 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0198-2022 |
| Event ID | 88859 |
| Event Description | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AZ, CA, HI, IL, KS, LA, MA, MD, MI, MO, MT, NE, NJ, NY, OH, OR, PA, RI, SC, TX, UT, VA, WA, WI and the country of Japan. |
| Quantity | 83 implants |
| Recall Reason | Packaged dental implant contains a different size then the size declared on the labeling. |
| Device Classification | 20211110 |
| Device Code Info | lot # 166300 / UDI: 10841307101796 |
| Center Classification Date | 20211103 |
| Recall Initiation Date | 20210923 |
| Recalling Firm | Implant Direct Sybron Manufacturing LLC |
| Initial Notification | Letter |
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