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Completed

Destino Twist 14F (also branded as Guidestar 14F)

FDA Recall Z-0646-2022 · Posted None

Recalling FirmOscor Inc.
Recall StatusCompleted
Product CodeDYB
Date Initiated2021-12-22
Product Quantity549 units

Reason for Recall

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Firm Action

Oscor issued customer letters to impacted consignees on January 7 and 11, 2022. Distributors are asked to immediately check inventory for affected product and quarantine any recalled devices. All downstream customers (hospitals/end users) should be identified and this recall should be communicated to those customers immediately. All retrieved inventory is to be returned to Oscor. An acknowledgement form must be completed and returned to Oscor via fax (727-934-9835) or via email to [email protected].

Root Cause

Process control

Distribution Pattern

Distribution to TN and PA in USA OUS distribution to Czech Republic

Official Source

View FDA Recall →

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

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