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 Initiated
- August 7, 2018
- Recall Number
- Z-0010-2020
- Quantity
- 158 devices
- Firm Location
- Westlake Village, CA
Reason for Recall
The incorrect device was packaged in the vial.
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.
Lot / Code Info
Lot 108191, UDI (01)10841307108313(17)230118(10)108191
Root Cause
Employee error
Action Taken
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.
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