FDAClass IIJanuary 8, 2014

Synthes Hand Switch - Electric Pen Drive recall

Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire…

Why was Synthes Hand Switch - Electric Pen Drive recalled?

Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number 05.001.012, lot number AV18166

Product
Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire…
Recalling firm
Synthes USA HQ, Inc.
Quantity
290
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .
Recall date
January 8, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls