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Terminated

6.5MMX165MM CANNULATED SCREW

FDA Recall Z-0143-2022 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeHWC
Date Initiated2021-09-20
Date Terminated2023-03-24
Product Quantity5 units

Reason for Recall

The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded.

Firm Action

Smith & Nephew issued a customer letter via email dated September 20, 2021. Consignees are asked to inspect inventory and locate any devices from the listed product and batch numbers enclosed with the Urgent Medical Device Recall Notice, and quarantine them immediately. Consignees must complete the enclosed response form, sign and send to [email protected]. Response form shall be completed even if there is no impacted product on hand.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of OK, TN and the country of Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060736SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWSSmith & Nephew, Inc. · 2006-04-18

Official Source

View FDA Recall →

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

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