Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helica

FDA device recall Z-0369-2014 · posted 2013-11-20 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

Reason for recall

A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.

Action taken

Synthes sent a Field Safety Notice dated October 3, 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 review the options provided in the Field Safety Notice to clarify and mitigate the potential risk. Customers were asked to prepare a list of the affected part and lot numbers and contact the Complaint Unit at 610-719-5596 to receive a Return Authorization Number. Complete and return the Verification Form with the product and Return Authorization number. Customers were also asked to forward the Field Safety Notice to anyone in their facility that needs to be informed. Customers were asked to maintain a copy of the Field Safety Notice. Customers with questions were asked to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Root cause

Process control

Status

Terminated

Product code

HSB

Quantity affected

350195

Distribution

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

Date initiated

2013-10-03

Date posted

2013-11-20

Date terminated

2016-08-18

Location

West Chester, PA

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