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Synthes 4.5MM TI VA-LCP CRVD Condylar Plate/6H/159MM/RT-STER recallZ-0401-2014 · Synthes USA HQ, Inc. · initiated May 29, 2013

Class II Terminated All recalls posted in November 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Synthes USA HQ, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Employee error

What the company is doing

Synthes sent a letter dated November 7, 2013, to the implanting surgeon to follow up on a complaint received. The firm requested any additional information the surgeon might have about the use of the plate as well as a status on the patient following use. For questions the surgeon was instructed to call 800-620-7025. For questions regarding this recall call 610-719-5000.

Recall details

Recall number
Z-0401-2014
Recall class
Class II
Status
Terminated
Initiated by the company
May 29, 2013
Posted by the FDA
Nov 26, 2013
Recalling firm
Synthes USA HQ, Inc.
Quantity
1
Product code
JDP
FDA submissions
K110354
Distribution
US Distribution in Colorado.

Product description

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.

Code information (models, lots, serial numbers)

part 04.124.406S, lot 3771678.

Other devices under the same FDA submission

78 devices cleared under K110354 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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