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Recall Observatory FDA recall evidence

Device product

SwishTapered Implant

Z-1112-2017

December 12, 2016

Class II

Product summary

Firm
Implant Direct Sybron Manufacturing, LLC
Event
Event 76111
Status
Terminated
Classification
Class II
Quantity
17
Official record key
device-enforcement:Z-1112-2017

Official wording

Reason: 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.

Code information: 933308 Lot # 73241

Distribution pattern: U.S. distribution to the following; NM, TX, CA, OR, OH, ME. Foreign distribution to the following; Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.