ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, Sterile. The incorrect cap label shows part 855708, 5.7mmD Platform, 8mmL.
- Recall Initiated
- November 15, 2016
- Terminated
- June 4, 2018
- Recall Number
- Z-1920-2018
- Quantity
- 18 units
- Firm Location
- Westlake Village, CA
Reason for Recall
The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.
Distribution
Distribution was made to FL, GA, MD, MI, NC, NY, OR, TX, UT and VA. There was no foreign/military/government distribution.
Lot / Code Info
Lot #71729
Root Cause
Labeling mix-ups
Action Taken
Letters dated 11/14/2016 were issued via FedEx overnight on 11/15/2016.
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