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Terminated

Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST

FDA Recall Z-0776-2020 · Posted None

Recalling FirmNextremity Solutions
Recall StatusTerminated
Product CodeHWC
Date Initiated2019-11-11
Date Terminated2020-09-10
Product Quantity87 units

Reason for Recall

Components 2mm shorter than indicated on the package label

Firm Action

Nextremity Solutions issued Urgent Medical Device Recall letter on 11/11/19 stating reason for recall, health risk and action to take: do not use, quarantine and return to Zimmer Biomet representative who will remove product, Contact customer service at 574-371-3071 between 8am -5pm(EST) M-F.

Root Cause

Packaging process control

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182201Stratum™ Foot Plating SystemNextremity Solutions, Inc. · 2018-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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