Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2529-2020 — PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be used for distraction in the anterior approach to the cervical spine.

U.S. FDA — Device Enforcement · United States · 2020-05-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2529-2020
Date of alert
2020-05-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
TeDan Surgical Innovations LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00851797006481
Reported risk: Lack of pouch seal. Product is labelled as sterile.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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