TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Packaging Damage
TeDan Surgical Innovations is recalling sterile distraction screws because damaged packaging may have exposed them to non-sterile conditions, posing an infection risk.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of infection to patients due to potential exposure to non-sterile conditions, which aligns with the rubric criteria for Severe severity.
Plain-English summary
TeDan Surgical Innovations LLC is recalling the DS-0024 Quick Start Distraction Screw 14mm 5/Box Sterile. The recall involves 146 boxes, specifically 48 boxes from Lot 2018022801 and 98 boxes from Lot 2018050801. These products were distributed worldwide.
The recall was initiated because the manufacturer discovered that the product packaging for the affected lots may be damaged. This damage potentially exposed the products to non-sterile conditions, despite being labeled as sterile. The FDA classifies this as a Class II recall.
The situation presents a risk of infection to patients. These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers. Healthcare facilities should stop using the affected lots and contact the manufacturer for instructions.
The recalled product
- Product
- DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.
- 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 (1)
- Item #: DS-0024 Lot #s: 2018022801 2018050801
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 recalled by TeDan Surgical Innovations LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · TeDan Surgical Innovations LLC
See all →- HighTeDan Phantom CS Distraction Screw Recalled for Lack of Pouch Seal
FDA (Devices) · 2020-07-15
- HighTeDan Phantom CS Quick Start Distraction Screw Recall for Seal Defect
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 · infection
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19