CLASS II Device recall · Reported 10 May 2017 · FDA Enforcement Report

Pediatric Craniotome, Bm recalled by The Anspach Effort

The Anspach Effort is recalling Pediatric Craniotome, Bm, distributed nationwide in the US. The recall was initiated on 6 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-X.
Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1983-2017
FDA event ID
76059
Recalling firm
The Anspach Effort, Palm Beach Gardens, FL
Classification
Class II
Status
Terminated
Recall initiated
6 Oct 2016
FDA classified
4 May 2017
Reported
10 May 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

6 Oct 2016Recall initiated by company
4 May 2017Classified by FDA+210 days
10 May 2017Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

PEDIATRIC CRANIOTOME, BM Product Usage: Pneumatic system

Where it was distributed

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

Nationwide District of ColumbiaPuerto Rico

Questions about this recall

Is Pediatric Craniotome, Bm recalled?

Yes. The Anspach Effort recalled Pediatric Craniotome, Bm on 6 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-1983-2017.

Why was it recalled?

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

Which lots are affected?

All serial numbers shipped to customers prior to 09/27/2016; DFU 18-0062; Part No. B-TURQ-X.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from The Anspach Effort

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