medical Class II Updated 2017-02-08

Implant Direct Sybron Manufacturing, LLC recalls SwishTapered Implant

Recalled Product

SwishTapered Implant


Hazard / Issue

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.

Issued by

FDA

Affected States: NM, TX, CA, OR, OH, ME
Lot/Code Info: 933308 Lot # 73241
View official government recall

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