The Recall Desk
HighFDA (Devices)·Z-0596-2018·Announced 2018-02-21

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.

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 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.
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

Distributed nationwide across the United States.

The notice also names 16 states specifically: