FDA recall Z-2621-2023

Product

smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint

Reason for recall

The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

Distribution

OH, CT, TX, NC, CA, NE, NV

Key facts

Status

Ongoing

Initiation date

2023-08-31

Report date

2023-09-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2621-2023