Drug recall
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage…
FDA recall event 85701 · Class II · Biomet
Key facts
| Event ID | 85701 |
|---|---|
| Recall numbers | Z-2303-2020, Z-2304-2020, Z-2305-2020, Z-2306-2020, Z-2307-2020, Z-2308-2020, Z-2309-2020, Z-2310-2020, Z-2311-2020, Z-2312-2020, Z-2313-2020, Z-2314-2020 and 10 more |
| Recalling firm | Biomet |
| Product type | Devices |
| Products | A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures…, A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during…, A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures…, A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures…, A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during… and 17 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Distributed to the field without having completed design history files or design transfer activities |
| Initiation date | May 14, 2020 |
| Report date | Jun 17, 2020 |
| Termination date | Apr 8, 2021 |
| City | Miami |
| State | FL |
| Country | United States |
| FEI number | 3003506715 |
At a glance
- 10–99 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: