Drug recall
Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of…
FDA recall event 81038 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 81038 |
|---|---|
| Recall numbers | Z-0122-2019, Z-0123-2019, Z-0124-2019, Z-0125-2019, Z-0126-2019, Z-0127-2019, Z-0128-2019, Z-0129-2019, Z-0130-2019, Z-0131-2019, Z-0132-2019, Z-0133-2019 and 36 more |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures, Affixus Hip Fracture Nail 125 9 mm x 165 mm, Item Number 816709165 Product Usage: Intended for the fixation of fractures, Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures, Affixus Hip Fracture Nail 130 11 mm x 180 mm, Item Number 814511180 Product Usage: Intended for the fixation of fractures, Affixus Hip Fracture Nail Left 125 11 mm x 260 mm, Item Number 814411260 Product Usage: Intended for the fixation of fractures and 43 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open. |
| Initiation date | Aug 8, 2018 |
| Report date | Oct 24, 2018 |
| Termination date | Jul 30, 2020 |
| 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: