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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
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