Z-0830-2014 Class II Terminated
FDA device recall Z-0830-2014 was initiated by The Anspach Effort, Inc. on Mar 31, 2011 and is designated Class II. Reason for recall: Cutter was longer than was stated on the label The recall status is terminated (terminated Jul 18, 2019). Affected quantity: 29 cutting burs.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 5, 2014
- Initiation Date
- Mar 31, 2011
- Termination Date
- Jul 18, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 cutting burs
Product Description
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Reason for Recall
Cutter was longer than was stated on the label
Distribution Pattern
Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
Code Information
Lot #'s: D323038131 and D343038845
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0830-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026