—#50061

Product

Anspach BlackMax Pneumatic Motor System; ENT Surgical Drill, including handpiece and Accessories Attached. All Models; Black Motors; Anspach Effort, Inc., Palm Beach FL 33410.

FDA product code: ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K831756, K965080
Affected lot / code info: All Serial Numbers.

Why it was recalled

Incorrect Sterilization Process --The Operating Manual for the product contains an incorrect statement regarding the sterilization of the Autolube foot control. The manual states that the product can withstand ETO sterilization, but there is no data to support this process.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

Anspach issued an Urgent Device Correction letter on 11/27/06, to all manual holders advising them of the error and requested that they update the manual with the corrected instructions. A reply receipt confirming notification was included.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution

Timeline

Recall initiated: 2006-12-18
Posted by FDA: 2008-02-13
Terminated: 2012-07-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50061. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.