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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
Related recalls
Same manufacturer · Tedan Surgical Innovations Llc
See all →- HighTeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Distraction Screw Recall for Lack of Pouch Seal
FDA (Devices) · 2020-07-15
- HighTeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure
FDA (Devices) · 2020-07-15
- ModerateTeDan 3COR Distraction Screw Recall Due to Pouch Seal Defect
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
FDA (Devices) · 2020-07-15
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighTeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Sterility Concerns
FDA (Devices) · 2020-03-25
- SevereTeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Packaging Damage
FDA (Devices) · 2020-03-25
- HighTeDan 3COR Distraction Screws Recalled for Potential Sterility Compromise
FDA (Devices) · 2020-03-25
- HighTeDan Surgical Recalls 3COR Distraction Screws Due to Packaging Damage
FDA (Devices) · 2020-03-25
- HighTeDan 3COR Distraction Screw Recall Due to Sterility Seal Failure
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Distraction Screw Recalled for Sterility Seal Defect
FDA (Devices) · 2020-07-15