Drug recall
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number…
FDA recall event 69723 · Class II · Arthrosurface, Inc.
Key facts
| Event ID | 69723 |
|---|---|
| Recall numbers | Z-1110-2015, Z-1111-2015, Z-1112-2015, Z-1113-2015, Z-1114-2015 |
| Recalling firm | Arthrosurface, Inc. |
| Product type | Devices |
| Products | Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder…, Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic…, Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder…, Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic…, Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications. |
| Initiation date | Nov 24, 2014 |
| Report date | Feb 18, 2015 |
| Termination date | Mar 27, 2015 |
| City | Franklin |
| State | MA |
| Country | United States |
| FEI number | 3004154314 |
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: