—#115702

Product

ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K040076
Affected lot / code info: Part Numbers: 98-0005, 98-0011; Serial Numbers: 200390, 200379, 20030001, 20030002, 20035201, 20035202.

Why it was recalled

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Root cause (FDA determination)

Process design

Action the firm took

The Anspach Effort, Inc. sent an Urgent Medical Device Recall letter dated December 21, 2012 to all affected customers. The letter identified the affected products, problems and actions to be taken. Customers were instructed to remove and return the affected products and complete the attached reply form and return to The Anspach Effort Inc. For questions contact Anspach Product Support at (800) 327-6887. For questions regarding this recall call 561-494-3706.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

Timeline

Recall initiated: 2012-11-28
Posted by FDA: 2014-06-25
Terminated: 2014-08-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115702. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.