The Recall Desk
LowFDA (Devices)·Z-0732-2020·Announced 2020-01-01

AAP Implantate Drill CS 4.0 Recalled for Incorrect Instructions

AAP Implantate Ag is recalling 7 units of INTEGRA Drill CS 4.0 in Texas due to incorrect instructions for use.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences, and the issue is limited to documentation (incorrect instructions).

Plain-English summary

AAP Implantate Ag is recalling 7 units of INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425. The recall is limited to units distributed in Texas with Lot Code QS0007.

The recall was initiated because the products were distributed with incorrect instructions for use. No specific injuries or illnesses are reported in the source text.

Consumers and healthcare providers should stop using the affected products and contact the recalling firm for further instructions.

The recalled product

Product
INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425
Manufacturer
AAP Implantate Ag
Affected units
7

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 Code: QS0007

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 recalled by AAP Implantate Ag 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 →