Recall Z-1478-2022— Stryker Instruments

Name: FDA recall Z-1478-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-24

Class II · Ongoing

Class II FDA medical device recall by Stryker Instruments, initiated 2022-06-24. It names one FDA 510(k) clearance: K143320. Product: Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.. Reason: There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures..

Recalling firm: Stryker Instruments
Classification: Class II
Status: Ongoing
Initiated: 2022-06-24
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K143320 — Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsStryker Corp.·cleared 2015-04-23

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

Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

Reason for recall

There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures.

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