Drug recall
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
FDA recall event 92460 · Class II · Wright Medical Technology, Inc.
Key facts
| Event ID | 92460 |
|---|---|
| Recall numbers | Z-2105-2023 |
| Recalling firm | Wright Medical Technology, Inc. |
| Product type | Devices |
| Products | Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Jun 13, 2023 |
| Report date | Jul 12, 2023 |
| City | Memphis |
| State | TN |
| Country | United States |
| FEI number | 3010667733 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: