Tedan Surgical Innovations Recalls Sterile Distraction and XL Screws
Tedan Surgical Innovations is voluntarily recalling sterile distraction and XL screws because mechanical packaging failures may compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where sterility may be compromised, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Tedan Surgical Innovations LLC is voluntarily recalling sterile distraction screws and sterile XL screws. The affected products include distraction screws in 12mm, 14mm, and 16mm sizes sold under TSI, 3COR, DB Surgical, and American Surgical Products brands, and XL screws in seven sizes (90mm to 150mm) sold under the TSI brand.
The recall is due to a mechanical failure of the protective packaging tube. This failure may allow tube end plugs to dislodge, potentially causing the screw to exit the protective tube and pierce the outer sterile barrier pouch, which may compromise the product's sterility.
A total of 12,065 sterile distraction screws and 384 sterile XL screws are in distribution. The products were distributed worldwide, including the United States, Australia, and Taiwan. Specific lot numbers are listed in the official recall notice. Healthcare providers and consumers should stop using these products and contact Tedan Surgical Innovations for further instructions.
The recalled product
- Product
- Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold under TSI, 3COR, DB Surgical, and American Surgical Products brands and Sterile XL Screws of 7 different sizes: 90mm, 100mm, 110mm, 120mm, 130mm, 140mm, 150mm sold under TSI brand Sterile Distraction Sc
- Manufacturer
- Tedan Surgical Innovations Llc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot numbers: 019715
- 019716
- 019942
- 019943
- 019977
- 019978
- 020102
- 020103
- 020104
- 020105
- 020106
- 020107
- 020108
- 020609
- 020782
- 021539
- 021663
- 022097
- 022098
- 022099
Distribution
Distributed nationwide across the United States.
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