Zimmer Biomet Recalls Acromium Flange Sets Due to Cleaning Issues
Zimmer Biomet is recalling Acromium Flange Sets 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device with elevated bacterial endotoxin and residual debris, which poses a risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Acromium Flange Set (Custom product), Item No. PM555148, which is used for acromium replacement. The recall involves 219,988 units distributed nationwide in the United States and in 23 other countries, including Argentina, Australia, Brazil, Canada, and Japan.
The recall is being issued because elevated levels of bacterial endotoxin and residual debris remain on the devices due to a cleaning issue. The agency has classified this recall as Class II.
Healthcare providers and patients should contact Zimmer Biomet for further instructions regarding the affected devices.
The recalled product
- Product
- ACROMIUM FLANGE SET (Custom product) Item No. PM555148 - Product Usage: Arcomium replacement.
- 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)
- 662230
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
- ModerateZimmer Biomet Recalls Various Fixation Systems and Accessories
FDA (Devices) · 2019-11-13
- ModerateZimmer Biomet Recalls Ziptight Ankle Fixation Devices Due to Missing Tip Protectors
FDA (Devices) · 2018-03-07
- HighZimmer Biomet Recalls Segmental System Proximal Femoral Components
FDA (Devices) · 2018-04-25
- HighZimmer Biomet Recalls Custom Medical Devices Due to Packaging Adhesion
FDA (Devices) · 2019-11-13
- HighZimmer Biomet Recalls Connecting Bolts Due to Material Error
FDA (Devices) · 2018-08-29