—#160829

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.

FDA product code: HWE — Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Catalog ID: 532.021 VET Serial #: 190673

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: Internationally to Canada

Timeline

Recall initiated: 2017-09-29
Posted by FDA: 2018-01-11
Terminated: 2019-07-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #160829. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.