Z-0729-2014 Class II Terminated

Recalled by The Anspach Effort, Inc. — Palm Beach Gardens, FL

FDA device recall Z-0729-2014 was initiated by The Anspach Effort, Inc. on Dec 17, 2013 and is designated Class II. Reason for recall: Some carbide cutting burr fractured during use. The recall status is terminated (terminated May 9, 2016). Affected quantity: 28,562 products for the entire recall.

Recall Details

Product Type
Devices
Report Date
Jan 22, 2014
Initiation Date
Dec 17, 2013
Termination Date
May 9, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
28,562 products for the entire recall

Product Description

Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

Reason for Recall

Some carbide cutting burr fractured during use.

Distribution Pattern

Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.

Code Information

All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0729-2014
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.