Smith & Nephew Inc: Medical Device Recall in 2013 - (Recall #: Z-1996-2013)

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:

GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic

Product Classification:

Class II

Date Initiated: July 8, 2013

Date Posted: August 28, 2013

Recall Number: Z-1996-2013

Event ID: 65738

Reason for Recall:

The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).

Status: Terminated

Product Quantity: 9 units

Code Information:

Lot Number 12LM03798

Distribution Pattern:

International only: Germany, France, United Arab Emirates, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated