—#124751

Product

Anspach BLACKMAX-N (Pneumatic motor) and Autolube III (Foot Control). Cutting and shaping bone.

FDA product code: GEY — Motor, Surgical Instrument, Ac-Powered
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Serial # 1934, 3135, 50229989-3, and 31496704 (BLACKMAX-N) Serial # 80017906 (Foot Control)

Why it was recalled

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).

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

none

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: US Distribution: Maryland only.

Timeline

Recall initiated: 2012-06-11
Posted by FDA: 2014-01-06
Terminated: 2016-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124751. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.