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.
Other recalls by Wright Medical Technology
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FDA Device · Class II · 2026-10-07 · Wright Medical Technology - stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
FDA Device · Class II · 2024-04-10 · Wright Medical Technology - stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
FDA Device · Class II · 2023-05-03 · Wright Medical Technology - stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Device · Class II · 2023-05-03 · Wright Medical Technology - ORTHOLOC 3DSi CLAW II 4 HOLE Plate, Size 25MM, REF 402S0425, Bone fixation device
FDA Device · Class II · 2023-03-08 · Wright Medical Technology
All Wright Medical Technology recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2105-2023%22
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