FDA Recall
Terminated
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.
Recall: Z-0010-2020
·
Initiated August 7, 2018
Recall
- Recall Number
- Z-0010-2020
- Event Number
- 83086
- Firm
- Implant Direct Sybron Manufacturing, LLC
- FEI Number
- 3001617766
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- August 7, 2018
- Address
- 3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171
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.
Reason
The incorrect device was packaged in the vial.
Action
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.
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.
Quantity
158 devices