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Most Recent Recalls

Summary of all recalls from the FDA in August 2012 (FDA Recalls) which may impact on the Prostheses List (33 KB)


Summary of all recalls from the FDA in July 2012 (FDA Recalls) which may impact on the Prostheses List (149 KB)


Summary of all recalls from the FDA in May 2012 (FDA Recalls) which may impact on the Prostheses List (152 KB)


Smith & Nephew stops sale of optional metal hip part (as reported on June 1, 2012 by Mark Hollmer)
Source: FierceMedicalDevices

Smith & Nephew says its pulling an optional metal part used with its R3 hip replacement cup from the market, because it is dissatisfied with how the product performs clinically. Investors reacted harshly, driving the stock down by about 3% in early trading.

The U.K.-based device and medical technology company disclosed what it termed as a “voluntary market withdrawal” of an “optional metal liner component” for its R3 Acetabular system, which serves as the “socket” portion of a hip implant. Smith & Nephew said about 7,700 metal liners have been implanted since the piece first became available in 2007, mostly for stemmed total hip replacements. The component launched globally in 2009. Patients who have the liner as part of their implant are being urged to talk to their surgeons if they are dealing with any unusual symptoms.

“We regularly review the effectiveness of our products and are not satisfied with the clinical results of this component,” Chief Medical Officer Andy Weymann explained in a statement, without elaborating on specific problems.

A Smith & Nephew spokesman told FierceMedicalDevices that U.S. and European regulators have been notified of the company’s voluntary action, which was based on clinical data from multiple sources. Among them: The U.K. National Joint Registry shows a revision rate of 6.3% after four years for the part, according to the spokesman, and the Australian National Joint Replacement Registry shows a revision rate of 4.96% after two years.

The company cautioned in its statement that other R3 system liners, made of polyethylene (SN856) (and ceramic outside the U.S. SN855) aren’t affected by the market withdrawal. Smith & Nephew also downplayed the impact it would face taking the component off the market, noting that procedures using the part generated less than 1% of Smith & Nephew’s global hip implant revenue.

The R3 system itself has been an issue for the company in the past. Back in December of 2010, the FDA issued Smith & Nephew a warning letter regarding the company’s Tuttlingen, Germany facility that produces the implant. The FDA said that the company hadn’t performed adequate tests and that it failed to establish and maintain a process that would correct manufacturing problems. At the time, Smith & Nephew said it took initial action to resolve any FDA issues. (Other sites in the U.K. and U.S. also manufacture the device.)

No R3 Metal liners on the Prostheses List although mentioned in the NJRR?


Covidien recalls Roticulator staplers (as reported on May 21, 2012 by Damian Garde)
Source: FierceMedicalDevices

Covidien is recalling its Roticulator staplers around the world, citing a packaging issue that might have rendered some products non-sterile, MassDevice reports.

The company disclosed the recall in a release from its Hong Kong division, but told MassDevice it had not planned to issue a press release on the issue because it’s “not material.” Covidien warned that use of the impacted devices could lead to an increased risk of infection for patients, and the company has asked providers to quarantine and return the affected staplers.

The recall applies to two models of the Roticulator 55 ( AS036 – 355 nat. Utilisation) and three of the Roticulator 30 ( AS035 – 102 nat. utilisation), which are medical staplers used in abdominal, gastric and pediatric surgeries. Covidien discovered the issue in a routine audit of products, a spokesperson told MassDevice, and is working with the FDA to move forward with the recall.

It’s Covidien’s second recall in recent months, although this one is less serious than the last: In January, the company recalled its Duet tissue-reinforcement system ( AS177 – 2558 nat. utilisation) after reports of 13 serious injuries and three deaths tied to the device.


Allergan subpoenaed over Lap-Band obesity device (as reported on May 8, 2012 by Mark Hollmer)
Source: FierceMedicalDevices

Well, this is potentially ominous. Allergan ($AGN) has been slapped with a subpoena from the inspector general of the Department of Health and Human Services regarding the company’s Lap-Band obesity treatment device.

The company disclosed the subpoena about its gastric band implant in a recent regulatory filing without revealing any other details. A spokeswoman for the Irvine, CA company, also known for Botox wrinkle treatments, acknowledged to Bloomberg that it received the subpoena but otherwise declined to discuss the matter.

So what is all of this likely about? Bloomberg hits on what may be the reason. Last winter, as the article notes, a study in the journal Archives of Surgery found that nearly half of patients who had a gastric band implant either had no weight loss at all, or had to have the device taken out after 6 years. Over 40% of those patients also experienced long-term complications.

Separately, Consumer Reports recently took aim at implants including the Lap-Band, a device designed to help people loose weight through a silicon band that can tighten around a patient’s stomach, reducing how much food the organ can hold in order to help them eat less. Earlier this year, the magazine blasted results the company used to obtain a regulatory O.K. where 25% of 299 enrollees needed their bands taken out after three years. The reason: patients either faced complications or simply didn’t shed enough pounds.

Either way, there’s plenty at stake here. As Bloomberg reminds us, the product produced more than $203 million in revenue for Allergan in 2011. The company also gained an expanded clearance for the product in February 2011, allowing its use in a broader class of obese patients than its 2001 initial approval called for. Allergan has sold Lap-Band since acquiring its creator, Inamed Corp. in 2006.

Large problem if a problem:

Billing Code AW001 – First utilisation Jul2008 – Total Utilisation – 18,290


Summary of all recalls from the FDA in April 2012 (FDA Recalls) which may impact on the Prostheses List (118.50 KB)


The MITCH TRH modular head has been cancelled from the Australian Register of Therapeutic Goods and it cannot be used in Australia.

Prostheses List billing code Femoral heads impacted are SR051 (First Benefit Date Mar2006 , Utilisation = 329) , SR043 (First Benefit Date March 2006, Utilisation = 559), JU001 (First Benefit Date Feb 2012, Utilisation = N/A).

Note high revision is when used with un-cemented Stryker Accolade femoral stem ST575 (First Benefit Date Feb2001, Utilisation = 2,520) and SR027 (First Benefit Date March2006 , Utilisation = 2)

Also included by the TGA is the ENTRUST ICD’s which is in the FDA recall spreadsheet (168 KB) which you can extract the information from. The spreadsheet contains a summary of all recalls from the FDA in March 2012 (FDA Recalls) which may impact on the Prostheses List.


St. Jude yanks Brio deep brain stimulator (as reported on March 29, 2012 by MassDevice staff)

St. Jude Medical temporarily pulls its Brio deep brain stimulation device off the European market on the “fixable” issue of bodily fluids seeping into the device.

Devices listed on the Prostheses List which may be affected (see below):

Billing Code Product Category Assessment Body Product Group Product Sub-Group Min Benefit Sponsor Product Name Last Updated
SJ148 4 – Neurosurgical 4.4 – DEEP BRAIN STIMULATION (DBS) 4.4.3 – Leads 4.4.3.1 – Permanent Lead $    4,150.00 St Jude Medical Australia Pty Ltd Libra Deep Brain Stimulation System  – Leads 6142 – 6149 February 2012
SJ149 4 – Neurosurgical 4.4 – DEEP BRAIN STIMULATION (DBS) 4.4.3 – Leads 4.4.3.2 – Lead Extension $    2,100.00 St Jude Medical Australia Pty Ltd Libra Deep Brain Stimulation System – Lead Extensions 6345 and 6346 February 2012
SJ202 4 – Neurosurgical 4.4 – DEEP BRAIN STIMULATION (DBS) 4.4.1 – Implantable Pulse Generator 4.4.1.2 – Rechargeable Pulse Generator $  19,150.00 St Jude Medical Australia Pty Ltd Brio DBS Implantable Pulse Generator 6788 February 2012
SJ204 4 – Neurosurgical 4.4 – DEEP BRAIN STIMULATION (DBS) 4.4.2 – External Components 4.4.2.1 – Patient Programmer $    1,400.00 St Jude Medical Australia Pty Ltd Brio DBS Patient Controller 6856 February 2012
SJ234 4 – Neurosurgical 4.4 – DEEP BRAIN STIMULATION (DBS) 4.4.3 – Leads 4.4.3.2 – Lead Extension $    2,100.00 St Jude Medical Australia Pty Ltd Pocket Adaptor February 2012
SJ273 4 – Neurosurgical 4.4 – DEEP BRAIN STIMULATION (DBS) 4.4.3 – Leads 4.4.3.2 – Lead Extension $    2,100.00 St Jude Medical Australia Pty Ltd Deep Brain Stimulation extensions – eXtend Technology February 2012

For more information please visit http://www.massdevice.com/news/st-jude-yanks-brio-deep-brain-stimulator


Depuy – ASR Hip Replacement

Any Customers who has had any hip surgery prior to July 2003, is not subject to this recall.

If your hip surgery was after July 2003 please contact your orthopaedic surgeon who can then determine whether you received an ASR Hip which became available in July 2003.

For more information please visit http://www.depuysynthes.com/asrrecall/


Boston Scientific – Innova Self-Expanding Stent System

A medical device recall letter was issued urgently on 13 May 2011. It explains the issue, identifies the affected products and requires all distributors to stop further distribution and use of the product. Boston Scientific has requested all unused products be returned to them.

For more information please visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259764.htm


Life Scan – One Touch Verio Blood Glucose Monitoring System

This recall affects unit the where made during August to December 2010. Blood Glucose Monitoring Systems are giving ‘error 2′ warning messages when used in conditions of high temperature and/or humidity. In these conditions the patient may not get a blood glucose result.

For more information please visit http://www.tga.gov.au/safety/recalls-device-life-scan-110616.htm


 

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