Zimmer Biomet Recalls Echo Hip Stems Due to Potential Component Comingle
Zimmer Biomet is recalling 12 Echo Bi-Metric Hip Stems because they may have been mixed with a different model. The error could extend surgery time.
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, but the stated hazard is procedural (extension of surgery time) rather than a direct physiological injury or contamination, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 12 units of the ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. The recall involves lot 944680, which was distributed in the United States to California, Georgia, Illinois, Missouri, New York, and Virginia.
The recall was initiated because two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. This means the specific components may have been mixed with a different product line.
The potential health consequence of this error is the extension of surgery time required to find a replacement component. No injuries or illnesses have been reported in the source text.
The recalled product
- Product
- ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 12
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)
- lot 944680. UDI (01)00880304463370(17)280206(10)944680
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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