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U.S. Department of Health and Human Services

Class 2 Device Recall OSCILLATING SAW ATTACHMENT

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  Class 2 Device Recall OSCILLATING SAW ATTACHMENT see related information
Date Initiated by Firm September 29, 2017
Date Posted January 11, 2018
Recall Status1 Terminated 3 on July 30, 2019
Recall Number Z-0398-2018
Recall Event ID 78901
Product Classification Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Product OSCILLATING SAW ATTACHMENT

Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
Code Information Catalog ID: 532.021 VET  Serial #: 190673
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Dr
Palm Beach Gardens FL 33410-4235
For Additional Information Contact Jody Cadd
610-314-2106
Manufacturer Reason
for Recall		 This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
FDA Determined
Cause 2		 Under Investigation by firm
Action On November 15, 2017 the firm sent letter to their only consignee. Our records show that your facility has received the product subject to this removal. 1. Immediately review your inventory to identify and quarantine the affected product listed above in a manner that ensures the affected product will not be used. 2. Review, complete, sign and return the attached reply form on page 3 of this letter to your local DePuy Synthes sales organization in accordance with the directions on the form within 5 business days of receipt of this notification. 3. Return the affected product as soon as possible, but within 30 business days. 4. Forward this notice to anyone in your facility who needs to be informed. 5. If the affected product has been forwarded to another facility, contact that facility to arrange its return. 6. Maintain awareness of this notice until the product has been returned. 7. Keep a copy of this notice. We apologize for any inconvenience that this product recall (removal) may create and appreciate your cooperation with our request. Should you have any inquiries please do not hesitate to contact your DePuy Synthes sales consultant. Thank you for your attention and cooperation. For further questions, please call (610) 314-2106.
Quantity in Commerce 1
Distribution Internationally to Canada
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.
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