FDA-Device2017-02-08Class II
SwishTapered Implant
Implant Direct Sybron Manufacturing, LLC
Hazard
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
Sold states
U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
Affected count
17
Manufactured in
3050 E Hillcrest Dr, N/A, Westlake Village, CA, United States
Products
SwishTapered Implant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1112-2017Don't want to check this manually?
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