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DePuy Synthes Recalls Elastic Nails Distributed in U.S.

Inserter is prone to mechanical failure during surgery.

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By: Michael Barbella

Managing Editor

Johnson & Johnson’s DePuy Synthes is recalling 1,500 inserters of titanium elastic nails distributed in the United States, warning the product is prone to mechanical failure during surgery.

The company claims the nails could experience a break in the main shaft, a jam in the inserter or break in the crossbar. The inserters typically are used in surgeries to fix fractures in the long bones — either in the lower extremities of pediatric and small-statured patients or in the upper extremities of other adult patients. It also also be used in small long bone fractures in such areas as the carpal and tarsal bones.

DePuy Synthes sent a recall notice on Feb. 3 to affected customers explaining the recall and urging its immediate removal of the product to prevent the performance of emergency surgery involving it. The U.S. Food and Drug Administration (FDA) only recently disclosed the recall.

The company currently is developing a replacement and recovery plan for the involved devices but it doesn’t have enough inventory to completely remove and replace the nails. Instead, the company is proposing to remove and replace the device “in increments to prevent any adverse impact on the availability of the device for use on patients in trauma-related surgery events,” the FDA said in a statement. “…the immediate removal of the product would prevent the performance of emergency surgery…”

DePuy Synthes officials said the company would contact customers as replacements become available.

The titanium elastic nails recall is the latest recall in a string of quality-control issues for the consumer and medical conglomerate. It most recently initiated a recall for an electrophysiology cardiac catheter from Biosense Webster, it faces ongoing litigation for its faulty hip implants and is still battling attorneys over devices (including the power morcellator) used in minimally invasive hysterectomy procedure that could spread existing cancer in the body.

 

 

issued a recall last month for 1,500 inserters of titanium elastic nails distributed in the U.S., which the FDA has just disclosed. The warning was given because the inserter is prone to mechanical failure during surgery such as breakage in the main shaft, a jam in the inserter or breakage of the crossbar.

These inserter devices typically are used in surgeries to fix fractures in the long bones–either in the lower extremities of pediatric and small-statured patients or in the upper extremities for other adult patients. It can also be used in small long bone fractures in areas such as the carpal and tarsal bones.

In early February, DePuy Synthes said it sent a recall notice to affected customers explaining the recall and urging its immediate removal of the product to prevent the performance of emergency surgery involving it.

– See more at: http://www.orthospinenews.com/jjs-depuy-synthes-recalls-orthopedic-surgical-tool-but-not-ready-to-replace#sthash.V0oziIlD.dpuf

ohnson & Johnson’s ($JNJ) DePuy Synthes issued a recall last month for 1,500 inserters of titanium elastic nails distributed in the U.S., which the FDA has just disclosed. The warning was given because the inserter is prone to mechanical failure during surgery such as breakage in the main shaft, a jam in the inserter or breakage of the crossbar.

These inserter devices typically are used in surgeries to fix fractures in the long bones–either in the lower extremities of pediatric and small-statured patients or in the upper extremities for other adult patients. It can also be used in small long bone fractures in areas such as the carpal and tarsal bones.

In early February, DePuy Synthes said it sent a recall notice to affected customers explaining the recall and urging its immediate removal of the product to prevent the performance of emergency surgery involving it.

– See more at: http://www.orthospinenews.com/jjs-depuy-synthes-recalls-orthopedic-surgical-tool-but-not-ready-to-replace#sthash.V0oziIlD.dpuf

ohnson & Johnson’s ($JNJ) DePuy Synthes issued a recall last month for 1,500 inserters of titanium elastic nails distributed in the U.S., which the FDA has just disclosed. The warning was given because the inserter is prone to mechanical failure during surgery such as breakage in the main shaft, a jam in the inserter or breakage of the crossbar.

These inserter devices typically are used in surgeries to fix fractures in the long bones–either in the lower extremities of pediatric and small-statured patients or in the upper extremities for other adult patients. It can also be used in small long bone fractures in areas such as the carpal and tarsal bones.

In early February, DePuy Synthes said it sent a recall notice to affected customers explaining the recall and urging its immediate removal of the product to prevent the performance of emergency surgery involving it.

– See more at: http://www.orthospinenews.com/jjs-depuy-synthes-recalls-orthopedic-surgical-tool-but-not-ready-to-replace#sthash.V0oziIlD.dpuf
Johnson & Johnson’s ($JNJ) DePuy Synthes issued a recall last month for 1,500 inserters of titanium elastic nails distributed in the U.S., which the FDA has just disclosed. The warning was given because the inserter is prone to mechanical failure during surgery such as breakage in the main shaft, a jam in the inserter or breakage of the crossbar.
These inserter devices typically are used in surgeries to fix fractures in the long bones–either in the lower extremities of pediatric and small-statured patients or in the upper extremities for other adult patients. It can also be used in small long bone fractures in areas such as the carpal and tarsal bones.
In early February, DePuy Synthes said it sent a recall notice to affected customers explaining the recall and urging its immediate removal of the product to prevent the performance of emergency surgery involving it.
– See more at: http://www.orthospinenews.com/jjs-depuy-synthes-recalls-orthopedic-surgical-tool-but-not-ready-to-replace#sthash.V0oziIlD.dpuf

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