Z-2105-2023 Class II Ongoing
FDA device recall Z-2105-2023 was initiated by Wright Medical Technology, Inc. on Jun 13, 2023 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 106 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 12, 2023
- Initiation Date
- Jun 13, 2023
- 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2105-2023
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026