Recall Z-1011-2022— Stryker GmbH

Name: FDA recall Z-1011-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-28

Class II · Ongoing

Class II FDA medical device recall by Stryker GmbH, initiated 2022-03-28. It names one FDA 510(k) clearance: K112197. Product: Smart Toe II Intramedullary Arthrodesis Implant. Reason: The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity"..

Recalling firm: Stryker GmbH
Classification: Class II
Status: Ongoing
Initiated: 2022-03-28
Firm location: Selzach, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K112197 — MEMOMETAL INTRA-MEDULLARY BONE FASTENERMemometal Technologies·cleared 2011-11-17

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

Smart Toe II Intramedullary Arthrodesis Implant

Reason for recall

The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with Nickel sensitivity".

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