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Open, Classified

INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

FDA Recall Z-0548-2022 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeHRS
Date Initiated2022-01-04
Product Quantity8 units (US)

Reason for Recall

The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

Firm Action

The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of CA and OH.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073375NEWDEAL TIBIAXYS SYSTEMNewdeal Sas · 2008-02-21

Official Source

View FDA Recall →

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

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