FDA Device recall Z-2105-2023
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile
- FDA Device
- Class II
- ongoing
- Published 2023-07-12
On 2023-07-12 the FDA classified a Class II recall of Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile by Wright Medical Technology, citing 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 thr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2105-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-06-13 |
| Published | 2023-07-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Wright Medical Technology |
| Distribution | n/a |
Product
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
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.
Identifiers
| code_info | Lot numbers 2656815 and 2762126, UDI-DI 00889797003926. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2105-2023%22
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