Recall Z-0883-2020— Synthes, Inc.

Name: FDA recall Z-0883-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-16

Class II · Terminated

Class II FDA medical device recall by Synthes, Inc., initiated 2019-12-16, terminated 2020-06-08. It names one FDA 510(k) clearance: K103243. Product: 2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.. Reason: There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field..

Recalling firm: Synthes, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-12-16
Terminated: 2020-06-08
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEMSynthes (Usa)·cleared 2011-01-21

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

2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.

Reason for recall

There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

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