Zimmer Biomet Recalls Persona Partial Knee Spacer Blocks
Zimmer Biomet is recalling Persona Partial Knee Spacer Blocks because they may feel tight during trialing or appear loose in extension.
What this means for you
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 the source describes a risk-of-harm product (improper fit during surgery) where specific injuries have not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is conducting a recall for 430 units of Persona Partial Knee Spacer Blocks in sizes 8mm, 9mm, 10mm, 12mm, and 14mm. These medical devices are used to assist in partial knee arthroplasty surgery. The affected products were distributed nationwide in the United States.
The recall was initiated after complaints indicated that the spacer blocks have the potential to feel tight during range-of-motion trialing. Additionally, the final trial has the potential to appear looser in extension. The recall covers specific lot numbers including 63552644, 63579568, and others listed in the official notice.
Healthcare providers and patients should stop using the affected spacer blocks and contact Zimmer Biomet for further instructions. The FDA has classified this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Persona Partial Knee Spacer Blocks To assist in partial knee arthroplasty surgery
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 430
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 (4)
- 42-5399-035-08/09/10/12/14 (Sizes 8mm
- 9mm
- 10mm
- 12mm
Distribution
Distributed nationwide across the United States.
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