Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
FDA Recall #Z-2105-2023 — Class II — June 13, 2023
Product Description
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.
Recalling Firm
Wright Medical Technology, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
106 devices
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.
Code Information
Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated