Wright Medical Technology, Inc. Recall 92460
Description: Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Wright Medical Technology, Inc. Recall 92460 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2105-2023 |
Event ID | 92460 |
Event Description | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. |
Product Type | 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. |
Quantity | 106 devices |
Recall 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. |
Device Classification | 20230712 |
Device Code Info | Lot numbers 2656815 and 2762126, UDI-DI 00889797003926. |
Center Classification Date | 20230706 |
Recall Initiation Date | 20230613 |
Recalling Firm | Wright Medical Technology, Inc. |
Initial Notification | |
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