Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw i

FDA device recall Z-0615-2014 · posted 2013-12-31 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

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.

Action taken

Synthes sent an Urgent Notice: Medical Device Recall letter dated April 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product, remove from inventory, and return them to Synthes immediately for replacement. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. Complete the Verification Section at the end of the letter by checking the appropriate box indicating affected product has been located. Return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132 If customers do not have the affected product they should still complete the Verifcation Section at the end of the letter by checking the appropriate box and faxing the document to 610-251-9005 or email to: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450 or email FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.

Root cause

Process design

Status

Terminated

Product code

HWE

Quantity affected

290

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada. .

Date initiated

2013-04-15

Date posted

2013-12-31

Date terminated

2016-09-14

Location

West Chester, PA

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