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Arthroplasty Central Discuss Prestige Recall in the General Discussion forums; I posted this elsewhere a few months ago, but the FDA updated their site in December. In case you did ...

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  #1  
Old 01-14-2008, 12:51 PM
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I posted this elsewhere a few months ago, but the FDA updated their site in December. In case you did not see this:

http://www.accessdata.fda.gov/script...s.cfm?ID=64585

Medical Device Recalls
Class 2 Recall
Prestige Cervical Disc System, Implant Trial

Date Recall Initiated September 04, 2007

Date Posted December 19, 2007

Recall Number Z-0138-2008

Product Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA

Code Information Lot Numbers: CN07G002, CN07F006, 434150, CN06M009, CN6M016, and 506850

Recalling Firm/Manufacturer: Medtronic Sofamor Danek USA Inc
1800 Pyramid Place
Memphis , Tennessee 38132-1719

Information Contact: Bert Kelly, 901-396-3133

Reason For Recall: Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

Action: The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007. Instructions include requests to immediately quarantine the product and hold for recalling firm collection.

Quantity in Commerce: 196 units

Distribution: Nationwide
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Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
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  #2  
Old 01-16-2008, 11:20 AM
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From "Sir" Alastair:

I just spoke with Bert Kelly at Medtronic--the name and number listed on the FDA recall page as the contact person. The recall has to do with the sizing guide. He said that they were having different results depending on the size of the patient with the sizing guide so it has been redesigned to be consistent independent of patient size. He indicated that the recall was made in September and all the sizing guides involved were returned by October, so there are no recalled parts in the field. He also indicated that over 1000 Prestige ST's had been implanted since the summer (i.e., FDA approval). Whew!
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"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
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  #3  
Old 01-16-2008, 01:49 PM
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Will my neck be recalled?

Terry Newton
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1980 ruptured L4-L5
1988 ruptured SI-L5
1990 ruptured C5-C6
1994 ruptured C6-C7
1995 Hemi-Laminectomy C5-C6, C6-C7 Mayo Clinic
Bicycle Accident 2004
MRI, EMG, Facet Injections, Epidural Blocks, Lumbar Discogram.
Stenum Hospital Surgery November 4, 2006
Prestige Disc C5-C6, C6-C7
Maverick Disc S1-L5, L4-L5
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  #4  
Old 01-16-2008, 05:27 PM
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Terry, only if your neck came from these:

CN07G002, CN07F006, 434150, CN06M009, CN6M016, and 506850

It's sometimes difficult to make heads or tails (or necks?!) when you see these reports!
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"Harrison" - info (at) adrsupport.org
Fell on my ***winter 2003, Canceled fusion April 6 2004
Reborn June 25th, 2004, L5-S1 ADR Charite in Boston
Founder & moderator of ADRSupport - 2004
Founder Arthroplasty Patient Foundation a 501(c)(3) - 2006
Creator & producer, Why Am I Still Sick? - 2012
Donate www.arthropatient.org/about/donate
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  #5  
Old 01-16-2008, 05:55 PM
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If you can box up your neck, they'll evaluate it and get back to you with a replacement after a few weeks
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Laura - L5S1 Charitee
C5/6 and 6/7 Prodisc C
Facet problems L4-S1
Knee, Shoulder, Toe, Finger, Elbow Problems

Jim - no spine problem but lots of other fun medical challenges

"There are many Annapurnas in the lives of men" Maurice Herzog
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  #6  
Old 01-16-2008, 06:34 PM
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OH! NO! I am already the Bionic Man with a shoulder resection, hemi-laminectomy, 4 artificial discs, high cholesterol, and old age creeping in.

Thanks for the laughs.

Terry Newton
__________________
1980 ruptured L4-L5
1988 ruptured SI-L5
1990 ruptured C5-C6
1994 ruptured C6-C7
1995 Hemi-Laminectomy C5-C6, C6-C7 Mayo Clinic
Bicycle Accident 2004
MRI, EMG, Facet Injections, Epidural Blocks, Lumbar Discogram.
Stenum Hospital Surgery November 4, 2006
Prestige Disc C5-C6, C6-C7
Maverick Disc S1-L5, L4-L5
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