Zimmer Biomet Recalls ASI 2.0 Calcar Trimmer Shafts Due to Mating Failure
Zimmer Biomet is recalling 67 units of ASI 2.0 Calcar Trimmer Shafts 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 involves a medical device with a functional defect that could compromise surgical performance, but the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 67 units of the ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp (Mode Number: 110032332). The device is a general orthopedic manual surgical instrument. The recall is due to a potential issue where the end of the shaft could fail to effectively mate with the broach.
The affected units are identified by Lot Numbers 827310, 711160, and 203240. These products were distributed in the United States and in Canada, China, and the Netherlands.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with the defect.
The recalled product
- Product
- ASI 2.0 Calcar Trimmer Shaft for Use with Zimmer Rasp Mode Number: 110032332 Product Usage: The device is a general orthopedic manual surgical instrument
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 67
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 (3)
- Lot Numbers: 827310
- 711160
- 203240
Distribution
Distributed nationwide across the United States.
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