Recall Z-2463-2019— Allergan PLC
Class I · Ongoing
Class I FDA medical device recall by Allergan PLC, initiated 2019-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction. Reason: The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants..
- Recalling firm
- Allergan PLC
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2019-07-24
- Firm location
- Irvine, CA, United States
Product description
Komuro, Soft Touch, BIOCELL, INTRASHIEL, BioDIMENSIONAL breast implants, Styles KML, KMM, KLL, KLM Product Usage: Breast augmentation and Breast reconstruction
Reason for recall
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Data sourced from openFDA. This site is unofficial and independent of the FDA.