INTEGRA Drill CS 4.5 Recalled for Incorrect Instructions for Use
AAP Implantate Ag is recalling two units of INTEGRA Drill CS 4.5 in Texas due to incorrect instructions for use.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 by definition is unlikely to cause adverse health consequences. The issue is limited to documentation errors (incorrect instructions) with no reported injuries.
Plain-English summary
AAP Implantate Ag is recalling two units of INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453. The recall was initiated because the products were distributed with the incorrect instructions for use.
The affected products were distributed in Texas. The specific lot code for the recalled items is QR0013.
Consumers who have this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- Product
- INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453
- Manufacturer
- AAP Implantate Ag
- Hazard
- Affected units
- 2
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: QR0013
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.
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