Zimmer CAS Recalls Tibial Alignment Guides Due to Spike Breakage Risk
Zimmer CAS is recalling 78 Tibial Alignment Guides because spikes may bend or break during use.
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 risk-of-harm product (medical device) where the hazard is a potential mechanical failure (spike breakage) that could cause injury, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Zimmer CAS is recalling 78 units of the iASSIST Tibial Alignment Guide, an orthopedic stereotaxic instrument. The recall is due to a potential defect where the spikes on the device may bend or break during insertion or extraction from the tibia.
The affected devices were distributed nationwide, including to facilities in Alabama, Arizona, California, Colorado, Florida, Indiana, Michigan, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, and Wisconsin. The specific item number is 20-8011-013-00, and the affected lot numbers are 120265, 110623, 120659, 120794, 120659-1, 130134, 120793, and 130135.
Healthcare providers should stop using the affected devices and contact Zimmer CAS for instructions on how to return or replace them.
The recalled product
- Product
- Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
- Manufacturer
- Zimmer CAS
- Affected units
- 78
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 (9)
- Item Number: 20-8011-013-00
- Lot Numbers: 120265
- 110623
- 120659
- 120794
- 120659-1
- 130134
- 120793
- 130135
Distribution
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