Style 363 Saline-Filled BIOCELL textured Breast Implants recallZ-0851-05 · Inamed Corp · initiated May 5, 2005
Terminated All recalls posted in May 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Inamed Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Wrong size implant was mislabeled.
FDA root cause category: Employee error
What the company is doing
Firm sent letter by overnite mail on May 5, 2005. Follow-up phone calls were made to confirm reciept. Doctors are to review surgery records and evaluate ammount of saline used to determine the risk for folding occuring and if found a visit by the patient is recommended to further evaluate for folding.
Recall details
- Recall number
- Z-0851-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 5, 2005
- Posted by the FDA
- May 25, 2005
- Recalling firm
- Inamed Corp
- Quantity
- 6
- Product code
- FWM
- FDA submissions
- P990074
- Distribution
- WI, TN, TX, NY, AR
Product description
Style 363 Saline-Filled BIOCELL textured Breast Implants
Code information (models, lots, serial numbers)
UF6328, UF6330, UF6331, UM5056, UM5057, UM5059
Other devices under the same FDA submission
103 devices cleared under P990074 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NATRELLE Saline-Filled Breast Implants 68-360Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline580 reports
- NATRELLE Saline-Filled Breast Implants 68-330Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline528 reports
- NATRELLE Saline-Filled Breast Implants 68-390Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline446 reports
- NATRELLE Saline-Filled Breast Implants 68-420Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline443 reports
- NATRELLE Saline-Filled Breast Implants 68-300Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline379 reports
- NATRELLE Saline-Filled Breast Implants 68-450Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline323 reports
- NATRELLE Saline-Filled Breast Implants 68-480Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline322 reports
- NATRELLE Saline-Filled Breast Implants 68-510Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline297 reports
- NATRELLE Saline-Filled Breast Implants 68HP-350Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline288 reports
- NATRELLE Saline-Filled Breast Implants 68HP-500Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline270 reports
- NATRELLE Saline-Filled Breast Implants 68HP-400Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline265 reports
- NATRELLE Saline-Filled Breast Implants 68-270Allergan, Inc. · Prosthesis, Breast, Inflatable, Internal, Saline243 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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