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U.S. Department of Health and Human Services

Class 2 Device Recall Keyless Driver

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  Class 2 Device Recall Keyless Driver see related information
Date Initiated by Firm October 06, 2016
Create Date May 04, 2017
Recall Status1 Terminated 3 on July 26, 2019
Recall Number Z-1995-2017
Recall Event ID 76059
510(K)Number K965080  
Product Classification Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code BWN
Keyless Driver
Product Usage:
Pneumatic system
Code Information All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0095; Part No. DRIVER.
Recalling Firm/
The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Anne Brisson
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 121
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 = BWN and Original Applicant = THE ANSPACH EFFORT, INC.