Zimmer Biomet Recalls Persona Partial Knee System Impactor Pads
Zimmer Biomet is recalling 1,275 Persona Partial Knee System instruments because the impactor pad may fracture 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 fracture) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Zimmer Biomet, Inc. is recalling 1,275 units of the Persona Partial Knee System instruments. These instruments are used by surgeons to facilitate the implantation of partial knee components during unicondylar knee replacement surgery.
The recall is being conducted because there is a potential for the Persona Partial Knee Impactor Pad to fracture. The affected products were distributed nationwide in the United States to the states of AZ, CA, CO, ID, IL, IN, MA, MD, MI, NJ, NM, PA, SC, TX, WA, and WI. The products were also distributed internationally to Belgium, France, Germany, Italy, Japan, the Netherlands, Spain, Sweden, Switzerland, and the UK.
The affected items are identified by Item No. 42539909100 and specific lot numbers including 63517759, 63555750, 63555752, 63561883, 63561884, 63594911, 63594914, 63698564, and 63705328. Healthcare facilities and users should stop using the affected impactor pads and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- Persona Partial Knee System Product Usage: The Persona Partial Knee System instruments are used by a surgeon to facilitate the implantation of PPK implantable components into the medical knee compartment during unicondylar knee replacement.
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 1,275
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 (10)
- Item No. 42539909100
- Lot No. (UDI No.): 63517759 ((01) 00880304810242 (10) 63517759)
- 63555750 ((01) 00880304810242 (10) 63555750)
- 63555752 ((01) 00880304810242 (10) 63555752)
- 63561883 ((01) 00880304810242 (10) 63561883)
- 63561884 ((01) 00880304810242 (10) 63561884)
- 63594911((01) 00880304810242 (10) 63594911)
- 63594914 ((01) 00880304810242 (10) 63594914)
- 63698564 ((01) 00880304810242 (10) 63698564)
- 63705328 ((01) 00880304810242 (10) 63705328)
Distribution
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