—#132446

Product

16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

FDA product code: HBC — Motor, Drill, Electric
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K133604
Affected lot / code info: Serial Numbers: H38309606702, H38309606704, H38309610105, H38309610104, H38309606701, H38309606703, H38309606705, H38309610101.

Why it was recalled

Customer complaint indicating the color bands on the MIA16-G1 were not correct.

Root cause (FDA determination)

Environmental control

Action the firm took

Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice. If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to the states of: NC and CA., and Internationally to Switzerland.

Timeline

Recall initiated: 2014-12-10
Posted by FDA: 2015-02-02
Terminated: 2016-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132446. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.