The Recall Desk
ModerateFDA (Devices)·Z-0830-2014·Announced 2014-02-05

Anspach Twist Drill Recall Due to Incorrect Length Labeling

The Anspach Effort, Inc. is recalling 29 single-use sterile twist drills because the cutters were longer than stated on the label.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error regarding the physical dimensions of the device. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving minor labeling or specification errors.

Plain-English summary

The Anspach Effort, Inc. is recalling 29 units of the Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. These are single-use sterile bone cutting burs intended for prescription use only.

The recall was initiated because the cutter was longer than was stated on the label. The affected products are identified by Lot #s D323038131 and D343038845.

The products were distributed worldwide, including in the United States (California, Colorado, Indiana, Kentucky, Maryland, and Texas) and internationally to Japan, Taiwan, the United Kingdom, Sweden, and Germany. Users should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Affected units
29

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #'s: D323038131 and D343038845

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by The Anspach Effort, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →