Biomet Microfixation Recalls Hard Tissue Replacement Implants Due to Sterility Deficiency
Biomet Microfixation is recalling 54 custom-made Hard Tissue Replacement implants due to a potential sterility deficiency. The affected units were distributed in the US and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential sterility deficiency in a medical device, which poses a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Biomet Microfixation, LLC is recalling 54 units of Hard Tissue Replacement (HTR) Implants. These prescription-only, custom-made polymer implants are intended for bone replacement or augmentation to treat craniofacial voids or defects resulting from disease, injury, or surgical trauma. The recall is being conducted due to a potential sterility deficiency.
The affected units were sealed between April 28, 2016, and June 7, 2016. Distribution was worldwide, including specific US states such as Arizona, California, Florida, Missouri, New Hampshire, Pennsylvania, Texas, and Virginia, as well as international locations including Austria, Canada, England, Germany, Greece, Italy, the Netherlands, and South Africa.
Because the implants are custom-made for single-procedure use, patients who have already had the implants placed should contact their healthcare provider for guidance. Healthcare providers should contact Biomet Microfixation for instructions on managing the recall and ensuring patient safety.
The recalled product
- Product
- Hard Tissue Replacement (HTR) Implant, Rx only, for use in single procedure only. Custom made. HTR polymer implants are intended for bone replacement/augmentation for treatment of craniofacial voids/defects resulting from disease, injury, or surgical trauma.
- Manufacturer
- Biomet Microfixation, LLC
- Category
- Medical Device — Implants
- Affected units
- 54
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 (4)
- Custom made
- one per customer. Affected units were sealed between April 28
- 2016 and June 7
- 2016
Distribution
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