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TeDan Surgical Innovations LLC recalls DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These products are intended to be used by trai
Recalled March 25, 2020 · FDA recall Z-1505-2020 · TeDan Surgical Innovations
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. · FDA Class II
Units
Total 57 boxes (49 boxes for Lot 2017111301 and 48 boxes for Lot 2018031401)
Sold at
Worldwide.
Description
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.
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(s)
TeDan Surgical Innovations LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →