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Open, Classified

smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL

FDA Recall Z-0097-2018 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeJDS
Date Initiated2017-10-24
Product Quantity17 units

Reason for Recall

A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.

Firm Action

Smith & Nephew sent an Urgent Medical Device Recall Notice dated October 24, 2017, to all affected customers. The firm requested return of the product. Please follow the instructions on the attached Response Form. For further questions, please call (978) 749-1440.

Root Cause

Employee error

Distribution Pattern

US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040212TRIGEN INTERTANSmith & Nephew, Inc. · 2004-02-20

Official Source

View FDA Recall →

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

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