Recall Z-0457-2021— Stryker GmbH

Name: FDA recall Z-0457-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-25

Class II · Ongoing

Class II FDA medical device recall by Stryker GmbH, initiated 2020-09-25. It names one FDA 510(k) clearance: K122113. Product: Osteosynthesis Compression Staple EasyClip. Reason: The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used..

Recalling firm: Stryker GmbH
Classification: Class II
Status: Ongoing
Initiated: 2020-09-25
Firm location: Selzach, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K122113 — MEMORY METAL STAPLES, EASYCLIPStryker Corp.·cleared 2013-03-12

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

Osteosynthesis Compression Staple EasyClip

Reason for recall

The device has the potential to release nickel above the acceptable margin of safety in pediatric patients who weigh less than 20 kg (44.09 lbs) when 2 or more implants are used.

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