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Terminated

PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system

FDA Recall Z-1983-2017 · Posted None

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeBWN
Date Initiated2016-10-06
Date Terminated2019-07-26
Product Quantity3

Reason for Recall

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

Firm Action

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 [email protected]. 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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974025ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc. · 1998-07-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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