Drug recall
3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated…
FDA recall event 80193 · Class II · Zimmer Biomet, Inc.
Key facts
| Event ID | 80193 |
|---|---|
| Recall numbers | Z-2230-2018, Z-2231-2018, Z-2232-2018, Z-2233-2018, Z-2234-2018, Z-2235-2018, Z-2236-2018, Z-2237-2018, Z-2238-2018, Z-2239-2018, Z-2240-2018, Z-2241-2018 and 1 more |
| Recalling firm | Zimmer Biomet, Inc. |
| Product type | Devices |
| Products | 3.2MM X 510MM COCR THD TIP; 14-443053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone., 3.2MM X 560MM COCR THD TIP; 14-441053 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone., BALL TIP GUIDE WIRE 2.0MMX60CM; 469020 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone., BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone., BALL TIP GUIDE WIRE 3.2MMX98CM; 469060 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone. and 8 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm is recalling various trauma guide wires due to insufficient packaging design verification and exceeding the expected occurrence rate of complaints for sterile barrier failure. Guide wires… |
| Initiation date | May 16, 2018 |
| Report date | Jun 27, 2018 |
| Termination date | Apr 5, 2024 |
| 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: