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Recall Observatory FDA recall evidence

Device product

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

Z-2105-2023

June 13, 2023

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 92460
Status
Ongoing
Classification
Class II
Quantity
106 devices
Official record key
device-enforcement:Z-2105-2023

Official wording

Reason: 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.

Code information: Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.