Biomet Echo Hip Stems Recalled Due to Incorrect Size Etching
Biomet, Inc. is recalling four Echo Bi-Metric hip stems because the etching on the 11mm stems incorrectly indicated they were 13mm stems.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a labeling error (incorrect etching) without reporting any illnesses, injuries, or deaths, which aligns with the criteria for a Moderate severity score.
Plain-English summary
Biomet, Inc. is recalling four units of the Echo Bi-Metric Press-Fit Stems, specifically the 11mm x 135mm Collarless Porous Stem. The recall is due to a labeling error where the surgeon noticed that the 11mm hip stem had an etching indicating it was a 13mm stem.
The affected devices are identified by Catalog Number 192411 and Lot Number 244800. The products were distributed nationwide in the United States, including the states of Arizona, Maryland, and Kansas. These orthopedic implants are indicated for the treatment of noninflammatory degenerative joint disease, rheumatoid arthritis, and specific femoral fractures.
Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of the affected devices. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4)…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 4
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 (1)
- Catalog Number: 192411 and Lot Number Identification: 244800
Distribution
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