FDA recall Z-2105-2023

Product

Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.

Reason for recall

The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.

Distribution

There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.

Key facts

Status

Ongoing

Initiation date

2023-06-13

Report date

2023-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2105-2023