Zimmer Biomet Recalls 73 Calcar Trimmer Shafts for Mating Failure
Zimmer Biomet is recalling 73 units of the ASI 2.0 Calcar Trimmer Shaft because the shaft end may fail to mate effectively with the broach.
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 and involves a mechanical defect in a surgical instrument that could lead to procedural failure or injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 73 units of the ASI 2.0 Calcar Trimmer Shaft for Use with Biomet Rasp, Model Number 110032331. The recall was initiated because the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument.
The affected units are identified by Model Number 110032331 and Lots 784060 and 662870. These products were distributed in the United States to California, Indiana, Minnesota, New Jersey, New York, Arkansas, Louisiana, Ohio, Kentucky, Texas, and Colorado, as well as internationally to Canada, China, and the Netherlands.
Healthcare providers and facilities that have received these devices should stop using them and contact Zimmer Biomet for instructions on return or replacement. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 73
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 (2)
- Model Number: 11032331 Lots: 784060
- 662870
Distribution
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