Electric Handpiece EM Hand Control Product Usage: Electric system
FDA Recall Z-1947-2017 · Posted None
Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBC
Date Initiated2016-10-06
Date Terminated2019-07-26
Product Quantity32
Reason for Recall
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Firm Action
Consignees were sent a recall notice via mail, dated 10/10/2016. In the notice, the firm notifies consignees of the Directions For Use (DFU) correction that will include recommended servicing intervals. All DFUs distributed after 09/28/2016 will have the correct DFU. The recalling firm instructs consignees to review the service intervals provided for product received, forward the notification to necessary parties and/or facilities, and complete the attached Verification Form. Complete Verification Forms are to be sent by fax to 877-546-5069 or by email to [email protected]. Consignees are also asked to maintain a copy of the notice for their records. Any questions can be directed to Customer Service at 1-800-327-6887, option 1.
Root Cause
Under Investigation by firm
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.