Mentor MemoryGel Resterilizable Gel Sizer Recalled for Incorrect Instructions
Mentor Texas, LP. is recalling 45 units of MENTOR MemoryGel Resterilizable Gel Sizers because they contain incorrect instructions for use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 II, but the specific defect is a documentation error (incorrect IFU) with no reported injuries or illnesses, fitting the criteria for a Low severity documentation issue.
Plain-English summary
Mentor Texas, LP. is recalling 45 units of MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE breast prosthesis sizers. The recall was initiated because the Instructions for Use (IFU) provided in the affected units are incorrect. Specifically, the units contain the IFU intended for the MENTOR MemoryShape Resterilizable Sizer rather than the correct documentation for the MemoryGel model.
The affected units were distributed in the United States to the states of MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA. The source text does not specify the number of reported injuries or illnesses associated with this recall.
Healthcare providers and patients should verify the lot numbers of their sizers against the list provided in the official recall notice. If a unit is affected, it should be returned to Mentor Texas, LP. for replacement or credit.
The recalled product
- Product
- MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE. Breast prosthesis sizer.
- Manufacturer
- Mentor Texas, LP.
- Hazard
- Affected units
- 45
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 (20)
- 6790747-030
- 6684051-002
- 6685063-013
- 6728126-044
- 6822437-031
- 6685063-011
- 6728128-035
- 6702298-031
- 6838011-018
- 6733863-003
- 6733863-017
- 6701421-023
- 6696938-022
- 6824389-004
- 6719893-016
- 6687714-031
- 6834854-016
- 6839585-001
- 6849927-019
- 6675404-028
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