FDA recall Z-1920-2018

Implant Direct Sybron Manufacturing, LLC · Class II · device

Product

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.

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.

Key facts

Status: Terminated
Initiation date: 2016-11-15
Report date: 2018-05-30
Termination date: 2018-06-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Westlake Village, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1920-2018