Zimmer Biomet Recalls Comprehensive RS Cleat CAP Due to Contamination
Zimmer Biomet is recalling Comprehensive RS Cleat CAP devices because elevated levels of bacterial endotoxin and residual debris remain on the products 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 no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Comprehensive RS Cleat CAP, Item No. 110300. 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 were distributed nationwide in the United States and in several international 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. The total quantity of units involved is 219,988.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Comprehensive RS Cleat CAP, Item No. 110300
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 219,988
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)
- 126590 126600 502890 502900 502910 012080 941080
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
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · bacterial endotoxin
See all →- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- HighAtrium Medical Recalls Getinge PVC Thoracic Catheters Due to Endotoxin Testing
FDA (Devices) · 2026-09-16
- CriticalOptimal Balance Pharmacy Recalls Contaminated Glutathione Injection Vials
FDA (Drugs) · 2026-09-09
- CriticalVictory Medical Center Pharmacy Recalls Glutathione Vials Due to Contamination
FDA (Drugs) · 2026-08-19
Similar recalls
- HighZimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels
FDA (Devices) · 2017-04-26
- HighZimmer Biomet Recalls Reverse Shoulder Instrument Cases Due to Sterilization Validation
FDA (Devices) · 2019-07-24
- HighZimmer Biomet Recalls Polyethylene Knee Implants Due to Endotoxin Levels
FDA (Devices) · 2017-04-26
- HighBiomet Recalls RingLoc Hip System Components Due to Endotoxin Levels
FDA (Devices) · 2020-06-03
- HighZimmer Recalls Femoral Condylar Buttress Plates Due to Sterility Concerns
FDA (Devices) · 2014-01-08
- HighZimmer Biomet Recalls XP-CR Tibial Trays Due to Locking Bar Issue
FDA (Devices) · 2019-09-18