Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire r

FDA device recall Z-1313-2015 · posted 2015-03-23 · Terminated

Recall details

Recalling firm

Synthes, Inc.

Reason for recall

In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.

Action taken

Synthes sent an Urgent Medical Device Recall Notice, dated December 19, 2014, to all affected customers to provide updated information on additional lots identified. 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 to obtain a Return Authorization (RA) Number, complete the Verification Section at the end of the letter, and return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132. 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

249

Distribution

Nationwide Distribution

Date initiated

2014-12-19

Date posted

2015-03-23

Date terminated

2016-05-19

Location

West Chester, PA

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