Drug recall
Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.
FDA recall event 67131 · Class II · The Anspach Effort, Inc.
Key facts
| Event ID | 67131 |
|---|---|
| Recall numbers | Z-0631-2014, Z-0632-2014 |
| Recalling firm | The Anspach Effort, Inc. |
| Product type | Devices |
| Products | Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone., Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where the patient was diagnosed with Creutzfeldt-Jacob Disease (CJD). |
| Initiation date | Jun 11, 2012 |
| Report date | Jan 15, 2014 |
| Termination date | Apr 18, 2016 |
| City | Palm Beach Gardens |
| State | FL |
| Country | United States |
| FEI number | 1045834 |
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: