Z-2105-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2023
- Initiation Date
- June 13, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 106 devices
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.
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.
Code Information
Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.