Smith & Nephew Inc: Medical Device Recall in 2013 - (Recall #: Z-0943-2013)

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:

INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.

Product Classification:

Class II

Date Initiated: February 7, 2013

Date Posted: March 20, 2013

Recall Number: Z-0943-2013

Event ID: 64342

Reason for Recall:

75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.

Status: Terminated

Product Quantity: 69 units

Code Information:

Batch Number 12KM01206

Distribution Pattern:

Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.

Voluntary or Mandated:

Voluntary: Firm initiated