Zimmer Biomet Recalls 2nd Assist Knee Positioner Due to Packaging Breach
Zimmer Biomet is recalling 38,879 units of the 2nd Assist Knee Positioner because the sterile packaging barrier may be breached during distribution.
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 potential breach of sterile packaging for a medical device, which poses a risk of harm (infection) even though no injuries or illnesses have been reported in the source text. This aligns with the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is conducting a medical device recall for the 2nd Assist Knee Positioner (Item# 740026). The recall involves 38,879 units that were distributed nationally.
The recall is being conducted due to the potential for the sterile packaging barrier to be breached during distribution. This breach could compromise the sterility of the device.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- The 2nd Assist Knee Positioner
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 38,879
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)
- Item# 740026
Distribution
Distribution scope not specified by the agency.
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