In February 2015, a recall was issued for the Johnson & Johnson DePuy Synthes orthopedic tool that inserts titanium elastic nails to secure broken bones. The recall affects 1500 inserters that have been distributed across the United States since it first became available in the medical marketplace.
The Class II issued warning indicates that the orthopedic tool is prone to significant mechanical failure that can occur during surgery. Failures include breakage of the tool’s crossbar or main shaft along with the inserter becoming jammed during use.
The DePuy Synthes inserters are a functional tool used in various surgeries to repair long bone fractures. The tool inserts nails in the lower extremities of children or small-stature adults and can also be used for upper extremity repairs in adult patients. Surgeons also use the device to repair tarsal and carpal bones and other small long bone fractures.
Johnson & Johnson has not asked that the product be removed from use immediately. This is because it is often required in emergency surgeries. Instead, DePuy Synthes proposes to have the device removed and replaced in increments to ensure availability of the orthopedic tool in emergency situations.
The DePuy Synthes was recalled because of its potential for breaking during use, which could delay surgical procedures if an alternate inserter needs to be located to ensure the procedure is completed. In addition, broken pieces of the device might have the potential of causing significant damage to other structures or causing injury to the doctor. Breakage of the unit is often the result of constant hammering as is loosening the inserter and having components fall away.
A Class II Recall
The FDA issues Class II recalls on hazardous products that present no immediate danger of serious injury or death by its use. However, these products still present potential risks of injuries and death. In many situations, the FDA issues the recall as a preventative measure. However, there are still safety and health risk factors that must be considered.
The Food and Drug Administration handles Class II recalls similar to a Class I recall (the most serious type of recall), in that it works in tandem with manufacturers to notify consumers, surgeons and the public. In addition, the FDA assist manufacturers in creating plans to ensure that every recalled item is pulled from the medical marketplace as quickly as possible.
In many cases, the product has the potential of injuring or killing the consumer. This can occur even when the orthopedic device or tool continues to be sold in the medical marketplace with its manufacturing defect. In fact, many medical products are sold and used before any unforeseeable or unexpected risks are realized.
In some situations, manufacturers fail to ensure all proper steps are taken including warning consumers of safety and health risks that could occur when the product is used.
Other Johnson & Johnson Recalls
This is certainly not the only recall faced by Johnson & Johnson, but only the latest one in a long list of significant quality control issues in the devices, implants and tools sold by the medical conglomerate. In addition to the DePuy Synthes orthopedic tool recall, J & J faces ongoing litigation from various devices that include power morcellators, hip replacement units, transvaginal mesh implants and others.
Taking Legal Action
Patients who have suffered serious injuries as the result of a recalled device are likely entitled to file a claim or lawsuit against the manufacturer and surgeon for financial compensation. This is because their injuries often require revision surgery or other expensive procedures to repair the problem.
However, medical malpractice and product liability cases can be legally complicated and often requires the skills of a competent personal injury law firm to handle the case.
Personal injury attorneys can provide immediate legal action against all parties responsible for the injuries to hold them accountable through medical malpractice and product liability tort laws. A skilled Chicago Medical Device Defect Attorney can build a solid case for financial compensation to ensure victims and families receive adequate recompense for medical bills, lost wages, pain, suffering, mental anguish, discomfort and grief.
It is important to hire a lawyer now because filing a claim is time sensitive due to state and federal statutes of limitations.