Home / Recalls / TeDan Surgical Innovations LLC / Z-2527-2020

Z-2527-2020 Class II Terminated

Recalled by TeDan Surgical Innovations LLC — Sugar Land, TX

Recall Details

Product Type
Devices
Report Date
July 15, 2020
Initiation Date
May 15, 2020
Termination Date
September 8, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1965 screws (packaged into 393 boxes) - [5 screw per box]

Product Description

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

Reason for Recall

Lack of pouch seal. Product is labelled as sterile.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution including in the states of: AZ, CA, FL, GA, HI, IL, MA, MI, NC, NH, NJ, NY, NV, PA, PR, TN, TX, and WA . The countries of Australia, Canada, France, Philippines, Taiwan, U.A.E., and United Kingdom.

Code Information

Product Code: DS-0014 UDI Number: 00851797006450 Lot Number: 2018020801 2018061101

Other recalls by TeDan Surgical Innovations LLC

  • Z-2525-2020 Class II — 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be us (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-2526-2020 Class II — PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended t (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-2524-2020 Class II — 3COR DISTRACTION SCREW, 12 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)
  • Z-1504-2020 Class II — D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR Di (February 18, 2019)