TeDan Surgical Innovations Recalls Quick Start Distraction Screws Due to Sterility Concerns
TeDan Surgical Innovations is recalling Quick Start Distraction Screws because damaged packaging may have exposed the sterile products to non-sterile conditions, posing a risk of infection.
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 is classified as FDA Class II and involves a risk of infection due to potential loss of sterility, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TeDan Surgical Innovations LLC is recalling the DS-0022 Quick Start Distraction Screw 12mm 5/Box Sterile. The recall involves 57 boxes total, comprising 49 boxes from Lot 2017111301 and 48 boxes from Lot 2018031401. These products were distributed worldwide and are intended for use by trained surgeons with TSI distractors and screwdrivers.
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, noting that the situation presents a risk of infection to patients.
Healthcare providers and patients should stop using the affected lots immediately. The source text does not specify a particular action for consumers beyond the recall notice, but standard procedure for medical device recalls involves contacting the manufacturer or the FDA for further instructions on return or disposal.
The recalled product
- Product
- DS-0022 QUICK START DISTRACTION SCREW 12MM 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-0022 Lot #s: 2017111301 2018031401
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
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