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Recall Observatory FDA recall evidence

Device product

TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orthopedic surgery

Z-1132-2013

March 06, 2013

Class II

Product summary

Firm
Smith & Nephew Inc
Event
Event 64669
Status
Terminated
Classification
Class II
Quantity
23 units
Official record key
device-enforcement:Z-1132-2013

Official wording

Reason: One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).

Code information: Lot Number 12FM12182

Distribution pattern: Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).