Drug recall
Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17…
FDA recall event 62365 · Class II · Stryker Howmedica Osteonics Corp.
Key facts
| Event ID | 62365 |
|---|---|
| Recall numbers | Z-2084-2012 |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Stryker Orthopaedics received a report indicating that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot that guides the stem of the keel punch into the… |
| Initiation date | Dec 22, 2011 |
| Report date | Aug 1, 2012 |
| Termination date | Jun 13, 2013 |
| City | Mahwah |
| State | NJ |
| Country | United States |
| FEI number | 3003070421 |
At a glance
- 1–9 Products in this recall
- 10–99 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: