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Recall Observatory FDA recall evidence

Device product

Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER is used for buttressing multi fragmentary diatal femur fractures including: supra-condylar, intra-articular and extra articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.

Z-0401-2014

May 29, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 66723
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0401-2014

Official wording

Reason: A plate was inadvertently released to a sales consultant that was restricted for sale.

Code information: part 04.124.406S, lot 3771678.

Distribution pattern: US Distribution in Colorado.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A plate was inadvertently released to a sales consultant that was restricted for sale.