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Wright Medical Technology, Inc. recalls Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Recalled July 12, 2023 · FDA recall Z-2105-2023 · Wright Medical Technology
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. · FDA Class II
Units
106 devices
Sold at
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.
Description
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.
Product
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Manufacturer(s)
Wright Medical Technology, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →