Recall Z-0223-2020— Synthes (USA) Products LLC

Name: FDA recall Z-0223-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-16

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2019-09-16, terminated 2020-04-24. It names one FDA 510(k) clearance: K142838. Product: Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery. Reason: The subject product measures 4.0mm in diameter instead of 3.5mm..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2019-09-16
Terminated: 2020-04-24
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K142838 — Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC·cleared 2015-01-20

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

Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery

Reason for recall

The subject product measures 4.0mm in diameter instead of 3.5mm.

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