Recall Z-2170-2021— Stryker GmbH

Name: FDA recall Z-2170-2021
Creator: U.S. Food and Drug Administration
Published: 2021-05-27

Class II · Ongoing

Class II FDA medical device recall by Stryker GmbH, initiated 2021-05-27. It names one FDA 510(k) clearance: K131365. Product: Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S. Reason: The devices have a different inner diameter than the diameter specified on the outer box label..

Recalling firm: Stryker GmbH
Classification: Class II
Status: Ongoing
Initiated: 2021-05-27
Firm location: Selzach, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K131365 — T2 TIBIAL NAILING SYSTEMStryker Trauma AG·cleared 2013-10-10

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

Nail Insertion Sleeve, elastic T2 Tibia SPI ¿8-13 (SPI Elast. Sleeve 8-13), Catalog Number 18061407S

Reason for recall

The devices have a different inner diameter than the diameter specified on the outer box label.

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