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Implant Direct Sybron Manufacturing, LLC recalls SwishTapered Implant
Recalled February 8, 2017 · FDA recall Z-1112-2017 · Implant Direct Sybron Manufacturing
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. · FDA Class II
Units
17
Sold at
U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.
Description
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.
Product
SwishTapered Implant
Manufacturer(s)
Implant Direct Sybron Manufacturing, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →