Recall Z-0367-2022— Mentor Texas, LP.
Class II · Ongoing
Class II FDA medical device recall by Mentor Texas, LP., initiated 2021-09-30. FDA's recall record names no specific 510(k) clearance for this event. Product: MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.. Reason: Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device..
- Recalling firm
- Mentor Texas, LP.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-09-30
- Firm location
- Irving, TX, United States
Product description
MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured or smooth surface shells. Each implant is supplied sterile with a disposable fill tube and reflux valve.
Reason for recall
Due to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation of the affected device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.