***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than

FDA device recall Z-1657-2013 · posted 2013-07-02 · Terminated

Recall details

Recalling firm

The Anspach Effort, Inc.

Reason for recall

The RPM of the Motor Handpiece may be less than 80,000 RPM.

Action taken

Anspach Effort sent an "URGENT: Medical Device Correction" letter dated June 24, 2011 to their customers via mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a reply form promptly confirming receipt of their letter and return it by fax to the number provided on the form. If any of the affected products were distributed to other services or facilities, please forward this information as appropriate. For questions contact Anspach Customer Support at 800-327-6887 or email customer.support@synthes.com.

Root cause

Process control

Status

Terminated

Product code

NAV

Quantity affected

61 units

Distribution

Worldwide Distribution - USA Nationwide including the states of: AZ, CA, FL, KY, ME, MI, MO, OH, PA, TN, TX , VA, and the countries of: Australia, Egypt, Italy, Japan, Switzerland, Taiwan, and Turkey;

Date initiated

2011-06-24

Date posted

2013-07-02

Date terminated

2013-12-24

Location

Palm Beach Gardens, FL