FDA-Device2023-07-12Class II
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Wright Medical Technology, Inc.
Hazard
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.
Sold states
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.
Affected count
106 devices
Manufactured in
1023 Cherry Rd, N/A, Memphis, TN, United States
Products
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2105-2023Don't want to check this manually?
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