Recall Z-0631-2014
The Anspach Effort, Inc. · initiated June 11, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.
Codes / lots: Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)
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).
FDA-determined cause: Unknown/Undetermined by firm
Action taken
none
Details
- Recall number
- Z-0631-2014
- Initiated
- June 11, 2012
- Posted by FDA
- January 6, 2014
- Terminated
- April 18, 2016
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Quantity
- 4 ( BLACKMAX-N) and 1 (Foot Control)
- Distribution
- US Distribution: Maryland only.
- Recalling firm
- The Anspach Effort, Inc., Palm Beach Gardens, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0632-2014 Class II | Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting…Anspach was contacted by a hospital to inform Anspach that a Blackmax motor had been used in a case where… | 06/11/2012Terminated |