FDA-Device2018-03-21Class II
fastener, fixation, nondegradable, soft tissue
Zimmer Biomet, Inc.
Hazard
It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.
Sold states
TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT
Affected count
429 units
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
fastener, fixation, nondegradable, soft tissue
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1009-2018Don't want to check this manually?
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