FDA-Device2020-03-25Class II
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.
TeDan Surgical Innovations LLC
Hazard
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.
Sold states
Worldwide.
Affected count
Total=146 boxes (48 boxes for Lot 2018022801 and 98 boxes for Lot 2018050801)
Manufactured in
12615 W Airport Blvd Ste 200, Sugar Land, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1506-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief