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Terminated

Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.

FDA Recall Z-0406-2018 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeMDM
Date Initiated2017-10-23
Date Terminated2018-08-24
Product Quantity9 units

Reason for Recall

The expiration date provided on the label is incorrect.

Firm Action

The firm initiated their recall by an Urgent Medical Device Recall Notice on 10/23/2017. The letter identified the affected device and the reason for the recall, as well as the potential risk. The firm instructed users to please inspect their inventory and locate any unused devices from the list of product and batch numbers provided in the Notice. Affected devices must be quarantined immediately. Distributors, must notify their customers of the field action and ensure that the actions are carried out. The attached form should be completed and returned. Questions or concerns can be directed to [email protected].

Root Cause

Process change control

Distribution Pattern

Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.

Official Source

View FDA Recall →

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

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