Zimmer Biomet Recalls Hip Systems Due to Cleaning Issues
Zimmer Biomet is recalling various hip arthroplasty systems because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
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 3/5 (High).
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 involves a medical device with a risk of harm (bacterial endotoxin and debris) where specific injury or illness reports are not detailed in the source text, fitting the criteria for a High severity rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling various hip systems used for hip arthroplasty. The recall involves 219,988 units manufactured between January 2008 and May 2019. The affected devices were distributed nationwide in the United States and in several international countries, including Argentina, Australia, Brazil, Canada, and others.
The recall is being conducted because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue. This contamination presents a risk of infection or other adverse health consequences for patients who have received or may receive these implants.
Patients who have had these hip systems implanted should contact their healthcare provider to discuss the recall and any necessary follow-up care. Healthcare facilities should check their inventory for the specific item numbers and lot codes listed in the official recall notice to ensure no affected devices are used for future procedures.
The recalled product
- Product
- Various Hip systems, Item Nos. 104207 104212 104215 11-162809 11-162810 11-162811 11-162812 11-162813 21-103202 21-103203 21-103204 21-103205 21-103206 21-103207 21-103208 21-103209 21-103210 21-103211 21-103212 21-103215 21-104109 21-104110 21-104111…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 219,988
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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.
See all 15 products in this recall →Related recalls
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