DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX recall
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…
Why was DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX recalled?
The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item #: DS-0022 Lot #s: 2017111301 2018031401
- 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…
- Recalling firm
- TeDan Surgical Innovations LLC
- Quantity
- Total 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401)
- Distribution
- Worldwide.
- Recall date
- March 25, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)