Smith & Nephew, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0573-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.

Product Classification:

Class II

Date Initiated: November 9, 2015

Date Posted: January 13, 2016

Recall Number: Z-0573-2016

Event ID: 72866

Reason for Recall:

One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

Status: Terminated

Product Quantity: 20 units

Code Information:

Batch # 15GM07831

Distribution Pattern:

US Distribution to states of:FL, MO, IN and TX.

Voluntary or Mandated:

Voluntary: Firm initiated