Recall Z-0777-2020— Nextremity Solutions

Name: FDA recall Z-0777-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-11

Class II · Terminated

Class II FDA medical device recall by Nextremity Solutions, initiated 2019-11-11, terminated 2020-09-10. It names one FDA 510(k) clearance: K182201. Product: Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST. Reason: Components 2mm shorter than indicated on the package label.

Recalling firm: Nextremity Solutions
Classification: Class II
Status: Terminated
Initiated: 2019-11-11
Terminated: 2020-09-10
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K182201 — Stratum Foot Plating SystemNextremity Solutions, Inc.·cleared 2018-11-16

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

Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST

Reason for recall

Components 2mm shorter than indicated on the package label

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