Recall Z-0414-2021— Synthes (USA) Products LLC

Name: FDA recall Z-0414-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-21

Class III · Terminated

Class III FDA medical device recall by Synthes (USA) Products LLC, initiated 2020-09-21, terminated 2022-12-30. It names 2 FDA 510(k) clearances: K003275, K983766. Product: END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.. Reason: Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device".

Recalling firm: Synthes (USA) Products LLC
Classification: Class III
Status: Terminated
Initiated: 2020-09-21
Terminated: 2022-12-30
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K003275 — SYNTHES SYNMESH SPACER SYSTEMSynthes (Usa)·cleared 2001-04-23
K983766 — SYNTHES SYNMESHSynthes (Usa)·cleared 1998-12-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

END RING 22MM X 28MM LATERAL OR ANTERIOR/5 DEG (TI) Product Number: 495-398 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Reason for recall

Incorrectly Labeled 'general medical device,' printed on the statutory label of the SYNMESH CAGE SYSTEM instead of 'specially controlled medical device"

Data sourced from openFDA. This site is unofficial and independent of the FDA.