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Completed

SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws, model numbers/REF numbers KITM640, KITM645, and KITM740.

FDA Recall Z-1572-2022 · Posted None

Recalling FirmSAFE ORTHOPAEDICS LLC
Recall StatusCompleted
Product CodeNKB
Date Initiated2022-06-03
Product Quantity8 devices

Reason for Recall

The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

Firm Action

The recall letter was issued on 6/3/2022 via email to the firm's one U.S. customer. The email included a dealer recall letter, dealer response form, and a template letter for notification of any hospitals who received the product from the dealer. The letter requested the products be quarantined and the dealer should contact the hospitals who received the product to notify them of the incorrect patient labels.

Root Cause

Labeling Change Control

Distribution Pattern

Distribution was made to MD. There was no government/military distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201648Sterispine™ PSSafe Orthopaedics · 2020-07-30

Official Source

View FDA Recall →

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

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