Smith & Nephew Inc: Medical Device Recall in 2013 - (Recall #: Z-0131-2014)

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, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic

Product Classification:

Class II

Date Initiated: October 7, 2013

Date Posted: November 13, 2013

Recall Number: Z-0131-2014

Event ID: 66545

Reason for Recall:

Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.

Status: Terminated

Product Quantity: 4 units

Code Information:

Batch No. 13GM09505

Distribution Pattern:

USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated