Z-0398-2018Class II

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

Name: Z-0398-2018 OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during...
Creator: The Anspach Effort, Inc.
Published: 2017-09-29
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2017-09-29 / Terminated

FDA source

The Anspach Effort, Inc. began a recall of OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone... on 2017-09-29. FDA classified it as Class II and gives the reason as "This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0398-2018
Classification: Class II
Status: Terminated
Initiated: 2017-09-29
Posted: 2018-01-11
Terminated: 2019-07-30
Recalling firm: The Anspach Effort, Inc.
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.
Product code: HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Reason for recall: This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
FDA root cause: 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
Product codes and lots: Catalog ID: 532.021 VET Serial #: 190673

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0398-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0398-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-19

Product code HWE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)