Drug recall
Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb…
FDA recall event 67446 · Class II · Implantech Associates Inc
Key facts
| Event ID | 67446 |
|---|---|
| Recall numbers | Z-1063-2014 |
| Recalling firm | Implantech Associates Inc |
| Product type | Devices |
| Products | Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure. |
| Initiation date | Jan 29, 2014 |
| Report date | Feb 26, 2014 |
| Termination date | Mar 12, 2015 |
| City | Ventura |
| State | CA |
| Country | United States |
| FEI number | 1000142697 |
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: