Drug recall
BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item…
FDA recall event 85153 · Class II · Biomet, Inc.
Key facts
| Event ID | 85153 |
|---|---|
| Recall numbers | Z-1638-2020, Z-1639-2020, Z-1640-2020, Z-1641-2020, Z-1642-2020, Z-1643-2020, Z-1644-2020, Z-1645-2020, Z-1646-2020, Z-1647-2020, Z-1648-2020, Z-1649-2020 and 21 more |
| Recalling firm | Biomet, Inc. |
| Product type | Devices |
| Products | BIOMET Custom StageOne Hip Femoral Reinforcement, 9 X 125 MM, Stainless Steel, PMI Instrument, Sterile, Item CP161972., BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181., BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182., BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183., BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184. and 28 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters. |
| Initiation date | Feb 26, 2020 |
| Report date | Apr 15, 2020 |
| Termination date | Jul 29, 2021 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 1825034 |
At a glance
- 10–99 Products in this recall
- None 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: