Home / Recalls / TeDan Surgical Innovations LLC / Z-1504-2020

Z-1504-2020 Class II Terminated

Recalled by TeDan Surgical Innovations LLC — Sugar Land, TX

Recall Details

Product Type
Devices
Report Date
March 25, 2020
Initiation Date
February 18, 2019
Termination Date
January 12, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
199 boxes (995 individual screws)

Product Description

D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Distraction Screws and the TSI Quick Start Distraction Screws products are intended for the distraction in the anterior approach to the cervical spine from C2 thru C7. The products are to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

Reason for Recall

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.

Distribution Pattern

Worldwide.

Code Information

Item #: D-0014 2018050201

Other recalls by TeDan Surgical Innovations LLC

  • Z-2526-2020 Class II — PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended t (May 15, 2020)
  • Z-2528-2020 Class II — PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: (May 15, 2020)
  • Z-2529-2020 Class II — PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: (May 15, 2020)
  • Z-2530-2020 Class II — PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Usage (May 15, 2020)
  • Z-2527-2020 Class II — PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended t (May 15, 2020)
  • Z-2524-2020 Class II — 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be us (May 15, 2020)
  • Z-2525-2020 Class II — 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be us (May 15, 2020)
  • Z-1845-2020 Class II — Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; REF: (July 16, 2019)
  • Z-1506-2020 Class II — DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These (February 18, 2019)
  • Z-1505-2020 Class II — DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: These (February 18, 2019)