Recall Z-1260-2015— Synthes, Inc.

Class II FDA medical device recall by Synthes, Inc., initiated 2015-02-03, terminated 2016-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients. This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.. Reason: The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN..

Recalling firm

Synthes, Inc.

Classification

Class II

Status

Terminated

Initiated

2015-02-03

Terminated

2016-08-26

Firm location

West Chester, PA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.