Reported Sep 26, 2012 · Terminated
Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American…
Tedan Surgical Innovations LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tedan Surgical Innovations Llc · 12615 W Airport Blvd · Sugar Land, TX · 77478-6203
Is this the product you have?
- Sterile
- Distraction Screws of 3 different sizes
12mm14mm and 16mm sold under TSI3CORDB Surgicaland American Surgical Products brands and
- Sterile XL Screws of 7 different sizes90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Screws are intended for the distraction in the anterior approach to the cervical spine. Sterile XL Screws are intended for the fixation of the blade to the vertebral body to prohibit drifting in the extreme lateral approach to the lumbar spine
- Lot codes and dates
- Lot numbers
019715019716019942019943019977019978020102020103020104020105020106020107020108020609020782021539021663022097022098022099022122022123022124022371022372022790022791022792022794022795022796022827022828and 023266
- Lot numbers
- Amount recalled
- 12,065 Sterile Distraction Screws (2413 boxes); 384 Sterile XL Screws (128 boxes) in distribution
Where it was sold
- Nationwide
Why it was recalled
This letter is to notify you that several of our sterile screw products are being voluntarily recalled. Product sterility may be compromised due to a mechanical failure of the protective packaging tube. Tube end plugs may dislodge creating the potential for the screw to come out of the protective tube and then the sharp end of the screw pierce the outer sterile barrier pouch.
This product could cause temporary or reversible health problems — stop using it.
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