simply RePlant Implant recallZ-0010-2020 · Implant Direct Sybron Manufacturing, LLC · initiated Aug 7, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Implant Direct Sybron Manufacturing, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The incorrect device was packaged in the vial.
FDA root cause category: Employee error
What the company is doing
The recalling firm issued letters dated 8/7/2018 via FedEx or email on 8/7/2018 informing the consignee of the issue and requesting they review their inventory for the affected product and quarantine it until it is returned.
Recall details
- Recall number
- Z-0010-2020
- Status
- Terminated
- Initiated by the company
- Aug 7, 2018
- Recalling firm
- Implant Direct Sybron Manufacturing, LLC
- Quantity
- 158 devices
- Product code
- DZE
- FDA submissions
- K061319
- Distribution
- Distribution was made to AL, AZ, CA, CO, CT, FL, GA, ID, IL KY, MA, MD, NM, NV, NY, PA, and TX. There was no government/military distribution. Foreign distribution was made to Germany, Great Britain, Italy, Spain, Trinidad & Tobago, and UAE.
Product description
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Code information (models, lots, serial numbers)
Lot 108191, UDI (01)10841307108313(17)230118(10)108191
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- simply RePlant® Implant 604313UImplant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form1 recall22 reports
Product lines
Other devices under the same FDA submission
109 devices cleared under K061319 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- RePlant® Implant 604310Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form398 reports
- Legacy™1 Implant 803710Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form338 reports
- RePlant® Implant 605010Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form310 reports
- RePlant® Implant 603510Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form291 reports
- ScrewIndirect® Implant 403710Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form241 reports
- RePlant® Implant 604313Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form232 reports
- Legacy™1 Implant 803711Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form200 reports
- ScrewIndirect® Implant 403713Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form187 reports
- RePlant® Implant 604311Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form180 reports
- Legacy™1 Implant 804710Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form178 reports
- RePlant® Implant 603513Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form158 reports
- RePlant® Implant 603511Implant Direct Sybron Manufacturing LLC · Implant, Endosseous, Root-Form142 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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