Z-0830-2014Class II

Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs

Name: Z-0830-2014 Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs
Creator: The Anspach Effort, Inc.
Published: 2011-03-31
License: https://open.fda.gov/license/

The Anspach Effort, Inc. / initiated 2011-03-31 / Terminated / root cause: labeling and UDI

FDA source

The Anspach Effort, Inc. began a recall of Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs on 2011-03-31. FDA classified it as Class II and gives the reason as "Cutter was longer than was stated on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0830-2014
Classification: Class II
Status: Terminated
Initiated: 2011-03-31
Posted: 2014-01-27
Terminated: 2019-07-18
Recalling firm: The Anspach Effort, Inc.
Product: Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Product code: GFF Bur, Surgical, General & Plastic Surgery
Reason for recall: Cutter was longer than was stated on the label
Root cause tag: labeling and UDI
FDA root cause: Pending
Action: Anspach sent an Urgent Medical Device Product Removal letter dated March, 32, 2013, to all affeced customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inventory their batches and return the products for replacement. Customers needing assistance were instructed to contact Anspach at 800-327-6887. For questions regarding this recall, call 800-327-6887.
Quantity in commerce: 29 cutting burs
Distribution: Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
Product codes and lots: Lot #'s: D323038131 and D343038845

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0830-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0829-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27
Z-0830-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27

Product code GFF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)