TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device.
FDA Recall Z-1637-2014 · Posted 2014-05-20
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Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeJDS
Date Initiated2014-04-04
Date Terminated2017-07-01
Product Quantity1,253 units total
Reason for Recall
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
Firm Action
The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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