Date Initiated by Firm | October 06, 2016 |
Create Date | May 04, 2017 |
Recall Status1 |
Terminated 3 on July 26, 2019 |
Recall Number | Z-1946-2017 |
Recall Event ID |
76059 |
510(K)Number | K011444 |
Product Classification |
Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
|
Product | Electronic Foot Control with Direction or Irrigation Switches
Product Usage:
Electric system |
Code Information |
All product shipped prior to 09/27/2016; DFU 18-0085; Part No. E-FP-DIR/RR |
Recalling Firm/ Manufacturer |
The Anspach Effort, Inc. 4500 Riverside Dr Palm Beach Gardens FL 33410-4235
|
For Additional Information Contact | Anne Brisson 800-327-6687 |
Manufacturer Reason for Recall | Supplied Directions for Use (DFU) did not contain a recommended service interval. |
FDA Determined Cause 2 | Under Investigation by 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 Anspach4870@stericycle.com. 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. |
Quantity in Commerce | 207 |
Distribution | Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = ERL
|