OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical p

FDA device recall Z-0398-2018 · posted 2018-01-11 · Terminated

Recall details

Recalling firm

The Anspach Effort, Inc.

Reason for recall

This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

HWE

Quantity affected

1

Distribution

Internationally to Canada

Date initiated

2017-09-29

Date posted

2018-01-11

Date terminated

2019-07-30

Location

Palm Beach Gardens, FL