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Terminated

6381 M-1 Cot Fastener, catalog no. 6381000000

FDA Recall Z-1599-2018 · Posted None

Recalling FirmStryker Medical Division of Stryker Corporation
Recall StatusTerminated
Product CodeFPO
Date Initiated2018-03-09
Date Terminated2019-04-09
Product Quantity3

Reason for Recall

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Firm Action

On March 9, 2018, the recalling firm notified affected distributors of the issue via their electronic product field action management system, who in turn notified their customers through written communication. Customers were informed of the issue and instructed to do the following: 1. Locate the operations manual shipped with each unit listed on the attached business reply form and replace it with the corrected manual included with the letter. Dispose of the incorrect manual. 2. Return the enclosed business reply form to confirm receipt of this notification to [email protected] 3. If you have loaned or sold any of the products listed in this letter, please forward a copy of this notice to the new users and advise the firm of their new location in the space provided on the business reply form. 4. If you have disposed of any of these units, advise the firm of their obsolescence by providing the firm with their serial number in the space provided on the business reply form.

Root Cause

Labeling Change Control

Distribution Pattern

Product distributed to the Netherlands

Official Source

View FDA Recall →

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

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