Recalls / —

—#152317

Product

STANDARD CRANIOTOME, BLACK MAX

FDA product code

BWN — Table And Attachments, Operating-Room

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K974025

Affected lot / code info

All serial numbers shipped to customers; DFU 18-0062; Part No. B-GREEN.

Why it was recalled

Supplied Directions for Use (DFU) did not contain a recommended service interval.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

The Anspach Effort, Inc.

Address

4500 Riverside Dr, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern

Worldwide Distribution - US Nationwide in the states of HI, DC including PR and the countries of Guam and Japan

Timeline

Recall initiated

2016-10-06

Terminated

2019-07-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #152317. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.