Zimmer Biomet Recalls Compress Mini Compress Devices Due to Cleaning Issues
Zimmer Biomet is recalling Compress Mini Compress devices because elevated 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 is classified as FDA Class II. The hazard involves elevated bacterial endotoxin and residual debris, which poses a risk of harm to patients, but the source text does not report specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Compress Mini Compress medical devices. The recall is being conducted because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue.
The affected products include Item Nos. 178350 through 178759 and specific variations. The recall covers 219,988 units manufactured between January 2008 and May 2019. These devices are intended for uncemented use in procedures such as the correction of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
The devices were distributed nationwide in the United States and in countries including Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Italy, Netherlands, India, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Singapore, Taiwan, Thailand, Trinidad and Tobago, and Venezuela. Consumers and healthcare providers should contact Zimmer Biomet for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Compress, Mini Compress; Item Nos. 178350 178351 178352 178353 178354 178355 178356 178357 178358 178359 178360 178361 178362 178363 178364 178365 178366 178367 178368 178369 178370 178371 178372 178373 178464 178472 178480 178488 178496 178504…
- 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.
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