Drug recall
OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product…
FDA recall event 85837 · Class II · OrthoPediatrics Corp
Key facts
| Event ID | 85837 |
|---|---|
| Recall numbers | Z-2538-2020, Z-2539-2020 |
| Recalling firm | OrthoPediatrics Corp |
| Product type | Devices |
| Products | OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number 10-1008-4060 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction…, OrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number 10-1008-4070 - Product Usage: is intended for fixation of tendons and ligaments during orthopedic reconstruction… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | ShieldLoc implant component of the ACL Reconstruction Systemlots may be labeled with the incorrect size. Product labeled as 10-1008-4070 was found to have 10-1008-4060 product in the package. Product… |
| Initiation date | Jun 5, 2020 |
| Report date | Jul 15, 2020 |
| Termination date | May 25, 2021 |
| City | Warsaw |
| State | IN |
| Country | United States |
| FEI number | 3006460162 |
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: