—#124752

Product

Anspach B-Blue-S 11.25 cm attachment and Anspach B-Green Standard Craniotome. Cutting and shaping bone.

FDA product code: GFF — Bur, Surgical, General & Plastic Surgery
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Serial # 50152011-14 (B-Blue-S) Serial # 31447408 (B-Green)

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 #124752. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.