Smith & Nephew Inc: Medical Device Recall in 2013 - (Recall #: Z-1132-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 6, 2013

Date Posted: April 24, 2013

Recall Number: Z-1132-2013

Event ID: 64669

Reason for Recall:

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).

Status: Terminated

Product Quantity: 23 units

Code Information:

Lot Number 12FM12182

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated