FDA-Device2020-03-25Class II
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.
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 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401)
Manufactured in
12615 W Airport Blvd Ste 200, Sugar Land, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1505-2020Don't want to check this manually?
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