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Topics: Device Safety | Recalls | Regulatory
Stryker recalls spinal implant, gets 'deadly' FDA label
August 29, 2013 | By Damian Garde
Stryker is recalling its Oasys spinal device.--Courtesy of Stryker
Stryker ($SYK) is recalling lots of a device used in spinal surgeries, and the FDA has assigned its most serious tag to the problem, warning that using the device could result in serious injury or death.
At issue is the Oasys Occipito-Cervico-Thoracic System, a device designed to stabilize the junction between the occipital bone and vertebrae in the cervical spine. Stryker has received reports that a pin that connects the tulip head to the plate body can fracture, possibly causing blood loss, nerve injury and the need for revision surgery. The FDA put its Class I designation on the recall, a label reserved for potentially deadly malfunctions.
Stryker initiated the recall in May, warning customers to stop using the affected lots and ship them back to the company. In June, Stryker put out a note urging surgeons to conduct routine post-op evaluations on patients who already have Oasys implants, keeping an eye out for symptoms that may require revision procedures.
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Today, the company released a statement explaining the timeline of the recall but isn't commenting on how many implants are affected or how much it expects the action to cost.
And speaking of costs, Stryker is no stranger to forking over legal fees and settlements related to problematic implants. Last year's recalls of the Rejuvenate and ABG II hip implants have forced the devicemaker to pay more than $400 million and counting to cover lawsuits and revision surgeries, already $10 million more than the worst-case scenario CEO Kevin Lobo forecast back in January.
Those charges have wiped away profit gains for three straight quarters, and the company hasn't said when it expects to get out from under the issue. In Q2, $170 million in recall-related charges stole headlines from Stryker's 5% sales growth, as the Michigan devicemaker posted revenue gains in each of its three segments.
- read the FDA's note
- here's Stryker's statement
Stryker's sales up 5%, but recalls swallow profits
Zimmer owes Stryker $228M in patent lawsuit
Stryker confronts mounting metal hip recall lawsuits
PAR FOR THE COURSE
ONCE AGAIN! STRYKER GETS DEADLY LABEL FOR ITS SPINAL PRODUCT YET NOTHING IS BEING DONE TO ASSESS THE DAMAGE TO THE SPINES CAUSED BY THE iCERVICORE MoM device. THE CERVICORE
VICTIMS WERE INDUCED TO VOLUNTEER IN A STUDY THAT HAD THE CONDITIONAL IDE APPROVAL REVOKED BY THE FDA as far back as July, 2006. http://blue.regence.com/trgmedpol/surgery/sur127.pdf
What's more, there is mounting evidence that Stryker covertly coated the CerviCore metal on metal cervical spinal implant with their unapproved rBMP -OP-1 to enhance fusion. Check out the pseudo tumors - ectopic bone formation complications that were in evidence as early as 2 years post CerviCore implantation: www.CerviCoreSpine.com
Stryker never filed an application for an IDE for FDA approval to use the an unapproved biologic to enhance fusion of its metal on metal CerviCore Disc. Nor did Stryker disclosed this to the victims - which was another serious risk that Stryker failed to disclose to the FDA, along with the fact that Stryker never disclosed that Nickel was one of the alloys in the Cobalt Chromium Molybdenum ASTM. Stryker has a pattern of not disclosing metal alloys life threatening risks associated with the use of their spinal implant products, eg tumor formation, carcinogenic risks, genotoxicity leading to Metallosis. Osteosarcoma and wide spread systemic and autoimmune syndromes.
When is someone going to put a stop to this biomedical man slaughter committed with impunity by the device industry?
Read more: Stryker recalls spinal implant, gets 'deadly' FDA label - FierceMedicalDevices http://www.fiercemedicaldevices.com/story/stryker-recalls-spinal-implant-gets-deadly-fda-label/2013-08-29#ixzz2dNQJwPNO
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Stryker Spine - OASYS Midline Occiput Plate
Recall Class: Class I
Date Recall Initiated: May 30, 2013
Product: OASYS Midline Occiput Plate
The affected products were distributed from April 23, 2010, through February 12, 2013.
Product Codes and Lot Numbers: KWP; all lots
Manufacturing Part Number Product Description
48551044 OASYS MIDLINE OCCIPUT PLATE, SMALL
48551045 OASYS MIDLINE OCCIPUT PLATE, MEDIUM
48551046 OASYS MIDLINE OCCIPUT PLATE, LARGE
48551047 OASYS MIDLINE OCCIPUT PLATE, LARGE LONG
48551048 OASYS MIDLINE OCCIPUT PLATE, MINI
Use: The OASYS Midline Occiput Plate is part of the OASYS Occipito-Cervico-Thoracic System used to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput – T3). The OASYS Midline Occiput Plate provides stabilization at the junction between the occipital bone and the vertebrae in the cervical spine.
2 Pearl Court
Allendale, NJ 07401-1611
Reason for Recall:
Stryker has received reports indicating post-operative fracture of the pin that connects the tulip head to the plate body. This may cause serious adverse health consequences including blood loss, nerve injury, and the need for revision surgery to replace the fractured implant.
Public Contact: Questions should be directed to Michelle Barry, Stryker Regulatory Compliance Manager at 201-760-8287 or by email at email@example.com
FDA District: New Jersey District Office
On May 30, 2013, Stryker issued an Urgent Medical Device Recall requesting medical facilities to examine their inventory and immediately stop distributing or using the recalled lots. If a medical facility has the affected product in stock, it should be returned to Stryker.
On June 20, 2013, Stryker notified spinal implant surgeons recommending routine clinical and radiographic post-operative evaluation for patients with an implanted OASYS Midline plate. If a patient begins experiencing symptoms including pain, weakness, or numbness, more urgent evaluation is needed. For patients who have had a revision surgery, Stryker recommends routine post-operative care and follow-up.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.
Page Last Updated: 08/29/2013
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